Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
286 catalogue numbers from 00-7711-016-20, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
286catalogue numbers in this listing
46510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K032726 |
| Record published | 2015-09-17 |
| Record revised | 2024-02-19 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Lumen/inner diameter 22 to 32 mm; outer diameter 39 to 81 mm; length 15 to 190 mm |
| Distribution end date | 2018-10-02 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 00-7711-016-20 | 12/14 Neck Taper, Size 16.25 | In distribution | |
| 4364-28-055 | Lumen/Inner Diameter 28 mm | In distribution | |
| 00-7711-005-00 | 12/14 Neck Taper, Size 5 | In distribution | |
| 6728-91 | Lumen/Inner Diameter 28 mm | In distribution | |
| 6710-08-02 | Size 8 | In distribution | |
| 2347-22-18 | 4 mm Diameter | In distribution | |
| 00-7711-005-10 | 12/14 Neck Taper, Size 5 | In distribution | |
| 6250-45-30 | Length 30 mm | In distribution | |
| 6726-89 | O.D. Size J | In distribution | |
| 4364-28-063 | Outer Diameter 63 mm | In distribution | |
| 6722-09 | O.D. Size J | In distribution | |
| 4364-22-041 | Outer Diameter 41 mm | In distribution | |
| 6250-65-25 | 6.5, mm, Diameter | In distribution | |
| 4365-22-043 | Lumen/Inner Diameter 22 mm | In distribution | |
| 802303200 | 32 mm Diameter, -6 mm Neck Length | In distribution | |
| 4365-32-057 | Outer Diameter 57 mm | In distribution | |
| 65-7711-009-40 | 12/14 Neck Taper, Size 9 | In distribution | |
| 4365-28-073 | Lumen/Inner Diameter 28 mm | In distribution | |
| 4366-28-049 | Outer Diameter 49 mm | In distribution | |
| 4366-32-067 | Lumen/Inner Diameter 32.00 mm | In distribution | |
| 00-7711-010-10 | 12/14 Neck Taper, Size 10 | In distribution | |
| 00-7711-006-20 | 12/14 Neck Taper, Size 6 | In distribution | |
| 6728-06 | O.D. Size F | In distribution | |
| 4364-32-061 | Lumen/Inner Diameter 32 mm | In distribution | |
| 6710-11-01 | Size 11 | In distribution | |
| 2347-22-20 | 4 mm Diameter | In distribution | |
| 4364-32-071 | Lumen/Inner Diameter 32 mm | In distribution | |
| 802303203 | 32 mm Diameter, +3.5 mm Neck Length | In distribution | |
| 802204005 | 12/14 Taper, 40 mm Diameter, +10.5 mm, Neck Length | In distribution | |
| 9363-22-059 | Size 22mm/59mm | In distribution | |
| 4364-22-055 | Outer Diameter 55 mm | In distribution | |
| 6728-13 | O.D. Size N | In distribution | |
| 4364-28-077 | Outer Diameter 77 mm | In distribution | |
| 6624-65-15 | Length 15 mm | In distribution | |
| 9362-28-065 | Size 28 mm/65 mm | In distribution | |
| 6722-21 | Lumen/Inner Diameter 22 mm | In distribution | |
| 9362-32-069 | Size 32 mm/69 mm | In distribution | |
| 4366-32-063 | Lumen/Inner Diameter 32.00 mm | In distribution | |
| 6250-45-15 | 4.5, mm, Diameter | In distribution | |
| 802303201 | 32 mm Diameter, -3.5 mm Neck Length | In distribution | |
| 9362-44-061 | Size 44mm/61mm | In distribution | |
| 6710-09-02 | Size 9 | In distribution | |
| 00-7711-006-00 | 12/14 Neck Taper, Size 6 | In distribution | |
| 6722-13 | Lumen/Inner Diameter 22 mm | In distribution | |
| 6726-08 | Lumen/Inner Diameter 26 mm | In distribution | |
| 802503204 | 32 mm Diameter, +6 mm Neck Length | In distribution | |
| 6710-10-02 | Size 10 | In distribution | |
| 9362-28-075 | Size 28 mm/75 mm | In distribution | |
| 6710-04-02 | Size 4 | In distribution | |
| 6722-06 | Lumen/Inner Diameter 22 mm | In distribution | |
| 6722-10 | Lumen/Inner Diameter 22 mm | In distribution | |
| 9362-38-059 | Size 38 mm/59 mm | In distribution | |
| 802304002 | 40 mm Diameter, +0 mm Neck Length | In distribution | |
| 4366-28-071 | Lumen/Inner Diameter 28 mm | In distribution | |
| 9362-32-059 | Size 32 mm/59 mm | In distribution | |
| 802302803 | 28 mm Diameter, +3.5 mm Neck Length | In distribution | |
| 802203204 | 12/14 Taper, 32 mm Diameter, +7 mm, Neck Length | In distribution | |
| 802304001 | 40 mm Diameter, -3.5 mm Neck Length | In distribution | |
| 802303601 | 36 mm Diameter, -3.5 mm Neck Length | In distribution | |
| 4366-28-053 | Outer Diameter 53 mm | In distribution | |
| 802304401 | 44 mm Diameter, -3.5 mm Neck Length | In distribution | |
| 00-7711-022-20 | 12/14 Neck Taper, Size 22.5 | In distribution | |
| 6250-65-30 | Length 30 mm | In distribution | |
| 01.01012.444 | -8 mm Neck, 44 mm Diameter | In distribution | |
| 6250-65-50 | Length 50 mm | In distribution | |
| 00-9975-007-10 | In distribution | ||
| 4365-22-063 | Outer Diameter 63 mm | In distribution | |
| 4366-32-065 | Outer Diameter 65.00 mm | In distribution | |
| 2347-22-28 | Length 28 mm | In distribution | |
| 4366-32-069 | Lumen/Inner Diameter 32 mm | In distribution | |
| 6722-11 | O.D. Size L | In distribution | |
| 6726-03 | O.D. Size C | In distribution | |
| 00-7711-007-40 | 12/14 Neck Taper, Size 7.5 | In distribution | |
| 6728-08 | O.D. Size H | In distribution | |
| 2347-22-50 | Length 50 mm | In distribution | |
| 6726-12 | O.D. Size M | In distribution | |
| 6732-10 | O.D. Size K | In distribution | |
| 4365-32-065 | Lumen/Inner Diameter 32 mm | In distribution | |
| 9363-32-075 | Size 32mm/75mm | In distribution | |
| 9362-28-045 | Size 28 mm/45 mm | In distribution | |
| 6710-06-01 | Size 6 | In distribution | |
| 6624-65-40 | Length 40 mm | In distribution | |
| 6726-06 | O.D. Size F | In distribution | |
| 00-7711-006-40 | 12/14 Neck Taper, Size 6 | In distribution | |
| 4364-28-067 | Outer Diameter 67 mm | In distribution | |
| 802503604 | 36 mm Diameter, +3 mm Neck Length | In distribution | |
| 2347-22-38 | Length 38 mm | In distribution | |
| 9026-25-35 | 6 Degree Taper, 26 mm Diameter, 3.5 mm Neck Length | In distribution | |
| 6250-45-50 | 4.5, mm, Diameter | In distribution | |
| 6624-65-20 | Length 20 mm | In distribution | |
| 2347-22-34 | 4 mm Diameter | In distribution | |
| 2347-22-32 | Length 32 mm | In distribution | |
| 6710-05-02 | Size 5 | In distribution | |
| 4364-22-039 | Outer Diameter 39 mm | In distribution | |
| 9364-28-077 | Size 28mm/77mm | In distribution | |
| 00-7711-011-20 | 12/14 Neck Taper, Size 11 | In distribution | |
| 6726-13 | Lumen/Inner Diameter 26 mm | In distribution | |
| 00-7711-012-00 | 12/14 Neck Taper, Size 12.5 | In distribution | |
| 32-9026-48-10 | 6 Degree Taper, 22 mm Diameter, +3.5 mm Neck Length | In distribution | |
| 00-7711-011-40 | 12/14 Neck Taper, Size 11 | In distribution | |
| 6732-92 | O.D. Size M | In distribution | |
| 6710-09-01 | Size 9 | In distribution | |
| 9026-21 | 6 Degree Taper, 22 mm Diameter, +0.5 mm Neck Length | In distribution | |
| 802203205 | 12/14 Taper Skirted, 32 mm Diameter, +10.5 mm, Neck Length | In distribution | |
| 9362-26-065 | Size 26 mm/65 mm | In distribution | |
| 802503203 | 32 mm Diameter, +3 mm Neck Length | In distribution | |
| 6722-14 | O.D. Size P | In distribution | |
| 6710-12-01 | Size 12 | In distribution | |
| 6710-11-02 | Size 11 | In distribution | |
| 65-7711-009-10 | 12/14 Neck Taper, Size 9 | In distribution | |
| 4364-22-059 | Lumen/Inner Diameter 22 mm | In distribution | |
| 2347-22-26 | Length 26 mm | In distribution | |
| 6726-05 | Lumen/Inner Diameter 26 mm | In distribution | |
| 9362-32-077 | Size 32 mm/77mm | In distribution | |
| 6722-05 | O.D. Size E | In distribution | |
| 6728-10 | O.D. Size K | In distribution | |
| 6624-65-25 | 6.5 mm, Diameter | In distribution | |
| 9364-32-079 | Size 32mm/79mm | In distribution | |
| 00-7711-013-00 | 12/14 Neck Taper, Size 13.5 | In distribution | |
| 6710-01-02 | Size 1 | In distribution | |
| 9364-28-057 | Size 28mm/57mm | In distribution | |
| 65-7711-005-10 | 12/14 Neck Taper, Size 5 | In distribution | |
| 6732-88 | O.D. Size H | In distribution | |
| 802303202 | 32 mm Diameter, +0 mm Neck Length | In distribution | |
| 802203604 | 12/14 Taper, 36 mm Diameter, +7 mm, Neck Length | In distribution | |
| 6728-04 | O.D. Size D | In distribution | |
| 6726-10 | O.D. Size K | In distribution | |
| 65-7711-011-00 | 12/14 Neck Taper, Size 11 | In distribution | |
| 6732-13 | Lumen/Inner Diameter 32 mm | In distribution | |
| 9363-32-051 | Size 32mm/51mm | In distribution | |
| 00-5850-032-17 | 7 mm Tooth Height | In distribution | |
| 6710-05-01 | Size 5 | In distribution | |
| 802204401 | 12/14 Taper, 44 mm Diameter, -3.5 mm, Neck Length | In distribution | |
| 9362-22-063 | Size 22 mm/63 mm | In distribution | |
| 9362-22-051 | Size 22 mm/51 mm | In distribution | |
| 4366-32-055 | Lumen/Inner Diameter 32 mm | In distribution | |
| 6250-65-40 | Length 40 mm | In distribution | |
| 4365-32-067 | Outer Diameter 67 mm | In distribution | |
| 00-7711-005-20 | 12/14 Neck Taper, Size 5 | In distribution | |
| 9026-26-35 | 6 Degree Taper, 26 mm Diameter, 10.5 mm Neck Length | In distribution | |
| 6732-09 | Lumen/Inner Diameter 32 mm | In distribution | |
| 6710-03-01 | Size 3 | In distribution | |
| 802503202 | 32 mm Diameter, +0 mm Neck Length | In distribution | |
| 6710-01-01 | Size 1 | In distribution | |
| 4366-32-081 | Lumen/Inner Diameter 32 mm | In distribution | |
| 6722-12 | O.D. Size M | In distribution | |
| 6726-07 | Lumen/Inner Diameter 26 mm | In distribution | |
| 9363-32-049 | Size 32mm/49mm | In distribution | |
| 6710-02-01 | Size 2 | In distribution | |
| 6250-65-60 | 6.5, mm, Diameter | In distribution | |
| 6624-65-30 | 6.5 mm, Diameter | In distribution | |
| 6732-05 | Lumen/Inner Diameter 32 mm | In distribution | |
| 802302804 | 28 mm Diameter, +7 mm Neck Length | In distribution | |
| 6722-08 | Lumen/Inner Diameter 22 mm | In distribution | |
| 6710-03-02 | Size 3 | In distribution | |
| 9362-32-051 | Size 32 mm/51 mm | In distribution | |
| 4366-32-057 | Lumen/Inner Diameter 32 mm | In distribution | |
| 6250-65-20 | Length 20 mm | In distribution | |
| 00-7711-007-00 | 12/14 Neck Taper, Size 7.5 | In distribution | |
| 00-7712-009-64 | 0 mm Rasp, Size 9 | In distribution | |
| 6728-12 | Lumen/Inner Diameter 28 mm | In distribution | |
| 6732-89 | O.D. Size J | In distribution | |
| 00-7712-011-64 | 0 mm Rasp, Size 11 | In distribution | |
| 6732-14 | O.D. Size P | In distribution | |
| 00-7712-022-64 | 0 mm Rasp, Size 22.5 | In distribution | |
| 4364-22-047 | Lumen/Inner Diameter 22 mm | In distribution | |
| 802302801 | 28 mm Diameter, -3.5 Neck Length | In distribution | |
| 6728-09 | O.D. Size J | In distribution | |
| 6732-06 | Lumen/Inner Diameter 32 mm | In distribution | |
| 6726-11 | Lumen/Inner Diameter 26 mm | In distribution | |
| 6732-08 | O.D. Size H | In distribution | |
| 6250-65-35 | 6.5, mm, Diameter | In distribution | |
| 9363-28-069 | Size 28mm/69mm | In distribution | |
| 00-7711-009-10 | 12/14 Neck Taper, Size 9 | In distribution | |
| 2347-22-55 | 4 mm Diameter | In distribution | |
| 9363-32-057 | Size 32mm/57mm | In distribution | |
| 6250-45-20 | Length 20 mm | In distribution | |
| 9362-28-059 | Size 28 mm/59 mm | In distribution | |
| 6250-65-80 | Length 80 mm | In distribution | |
| 65-7711-011-20 | 12/14 Neck Taper, Size 11 | In distribution | |
| 9362-28-073 | Size 28 mm/73 mm | In distribution | |
| 6728-05 | O.D. Size E | In distribution | |
| 4364-22-057 | Outer Diameter 57 mm | In distribution | |
| 2347-22-36 | Length 36 mm | In distribution | |
| 6722-01 | O.D. Size A | In distribution | |
| 6722-02 | Lumen/Inner Diameter 22 mm | In distribution | |
| 6710-07-01 | Size 7 | In distribution | |
| 4366-32-071 | Outer Diameter 71 mm | In distribution | |
| 9363-28-049 | Size 28mm/49mm | In distribution | |
| 9362-32-057 | Size 32 mm/57 mm | In distribution | |
| 6726-02 | Lumen/Inner Diameter 26 mm | In distribution | |
| 6250-65-15 | Length 15 mm | In distribution | |
| 2347-22-16 | 4 mm Diameter | In distribution | |
| 9362-28-057 | Size 28 mm/57 mm | In distribution | |
| 00-5851-032-22 | In distribution | ||
| 802303204 | 32 mm Diameter, +7 mm Neck Length | In distribution | |
| 65-7711-015-00 | 12/14 Neck Taper, Size 15 | In distribution | |
| 6624-65-35 | Length 35 mm | In distribution | |
| 6728-07 | Lumen/Inner Diameter 28 mm | In distribution | |
| 9362-44-077 | Size 44mm/77mm | In distribution | |
| 4365-26-055 | Outer Diameter 55 mm | In distribution | |
| 9026-22-10 | 6 Degree Taper, 22 mm Diameter, +3.5 mm Neck Length | In distribution | |
| 4365-32-077 | Lumen/Inner Diameter 32 mm | In distribution | |
| 9362-38-081 | Size 38mm/81mm | In distribution | |
| 4364-22-051 | Outer Diameter 51 mm | In distribution | |
| 6250-45-25 | Length 25 mm | In distribution | |
| 9362-26-051 | Size 26 mm/51 mm | In distribution | |
| 4366-32-077 | Outer Diameter 77 mm | In distribution | |
| 6732-90 | O.D. Size K | In distribution | |
| 6722-03 | O.D. Size C | In distribution | |
| 4365-26-053 | Outer Diameter 53 mm | In distribution | |
| 6726-09 | Lumen/Inner Diameter 26 mm | In distribution | |
| 6726-04 | O.D. Size D | In distribution | |
| 00-7711-009-20 | 12/14 Neck Taper, Size 9 | In distribution | |
| 00-7712-016-64 | 0 mm Rasp, Size 16.25 | In distribution | |
| 6250-45-40 | Length 40 mm | In distribution | |
| 802302805 | 28 mm Diameter, +10.5 mm Neck Length | In distribution | |
| 9362-28-049 | Size 28 mm/49 mm | In distribution | |
| 6250-45-35 | Length 35 mm | In distribution | |
| 2347-22-24 | 4 mm Diameter | In distribution | |
| 4364-22-049 | Outer Diameter 49 mm | In distribution | |
| 4365-32-059 | Lumen/Inner Diameter 32 mm | In distribution | |
| 00-5851-032-21 | In distribution | ||
| 6722-04 | Lumen/Inner Diameter 22 mm | In distribution | |
| 6732-11 | O.D. Size L | In distribution | |
| 6624-65-50 | 6.5 mm, Diameter | In distribution | |
| 6726-14 | Lumen/Inner Diameter 26 mm | In distribution | |
| 6710-12-02 | Size 12 | In distribution | |
| 6722-07 | Lumen/Inner Diameter 22 mm | In distribution | |
| 2347-22-60 | Length 60 mm | In distribution | |
| 4366-28-079 | Lumen/Inner Diameter 28 mm | In distribution | |
| 4364-28-065 | Lumen/Inner Diameter 28 mm | In distribution | |
| 4366-32-063 | Lumen/Inner Diameter 32 mm | In distribution | |
| 6250-45-60 | Length 60 mm | In distribution | |
| 00-7712-005-64 | 0 mm Rasp, Size 5 | In distribution | |
| 6710-07-02 | Size 7 | In distribution | |
| 6732-07 | Lumen/Inner Diameter 32 mm | In distribution | |
| 00-7712-015-64 | 0 mm Rasp, Size 15 | In distribution | |
| 6728-11 | O.D. Size L | In distribution | |
| 6710-06-02 | Size 6 | In distribution | |
| 4365-22-065 | Lumen/Inner Diameter 22 mm | In distribution | |
| 9364-32-075 | Size 32mm/75mm | In distribution | |
| 802303603 | 36 mm Diameter, +3.5 mm Neck Length | In distribution | |
| 9364-32-081 | Size 32mm/81mm | In distribution | |
| 6624-65-60 | 6.5 mm, Diameter | In distribution | |
| 4365-32-071 | Outer Diameter 71 mm | In distribution | |
| 65-7711-022-20 | 12/14 Neck Taper, Size 22.5 | In distribution | |
| 6732-12 | O.D. Size M | In distribution | |
| 9363-28-071 | Size 28mm/71mm | In distribution | |
| 4362-00-100 | 4 | In distribution |
Showing 250 of 286 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
| VerSys® | Zimmer, Inc. | 229 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252623 | 2026-02-04 |
| K211047 | 2023-01-10 |
| K190656 | 2019-12-06 |
| K190660 | 2019-12-05 |
| K183457 | 2019-11-05 |
| K182678 | 2019-05-31 |
| K151448 | 2015-08-13 |
| K123019 | 2012-10-22 |
| K113296 | 2012-09-14 |
| K103662 | 2011-04-15 |
| K101229 | 2010-12-03 |
| K093561 | 2010-04-28 |
| K091508 | 2009-09-11 |
| K061461 | 2006-12-20 |
| K061226 | 2006-08-02 |
| K061786 | 2006-07-24 |
| K060040 | 2006-05-12 |
| K052321 | 2006-02-15 |
| K051491 | 2005-06-30 |
| K042337 | 2004-11-04 |
| K042776 | 2004-11-04 |
| K041109 | 2004-07-20 |
| K033034 | 2003-11-05 |
| K032726 | 2003-10-22 |
| K031572 | 2003-06-24 |
| K030733 | 2003-05-01 |
| K030079 | 2003-02-05 |
| K021891 | 2002-09-05 |
| K014070 | 2002-07-30 |
| K003478 | 2001-02-05 |
| K002960 | 2000-12-11 |
| K994286 | 2000-03-10 |
| K992667 | 1999-10-27 |
| K990135 | 1999-07-12 |
| K980711 | 1998-11-12 |
| K973714 | 1997-12-24 |
| K964769 | 1997-02-13 |
| K953337 | 1996-01-22 |
| K954698 | 1996-01-17 |
| K953490 | 1995-10-20 |
| K934515 | 1995-03-07 |
| K934765 | 1994-04-29 |
| K922071 | 1994-02-22 |
| K921557 | 1994-02-22 |
| K921308 | 1994-02-22 |
| K921639 | 1992-07-02 |
Recalls Naming This Product
63 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 416 units | |
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 215 units | |
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 167 units | |
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 158 units | |
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 160 units | |
| Zimmer, Inc. | UDI-DI | 2023-07-26 | Class II | Mixed-up of materials/components | The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa. | 24 units | |
| Zimmer, Inc. | 510(k) number | 2023-02-27 | Class II | Under Investigation by firm | Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in fl | 1,168 untits | |
| Zimmer, Inc. | 510(k) number | 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 280 | 2020-05-28 |
| Zimmer, Inc. | 510(k) number | 2018-03-29 | Class II | Under Investigation by firm | There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process. | 1,145 distribution events. Note that this product is lot con | 2019-12-17 |
| Zimmer, Inc. | 510(k) number | 2018-03-01 | Class II | Labeling mix-ups | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant. | 12 | 2019-07-18 |
| Zimmer, Inc. | 510(k) number | 2018-03-01 | Class II | Labeling mix-ups | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant. | 24 | 2019-07-18 |
| Zimmer, Inc. | 510(k) number | 2017-08-01 | Class II | Package design/selection | The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier. | 38,069 units total | 2020-03-18 |
| Zimmer, Inc. | 510(k) number | 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| Zimmer, Inc. | 510(k) number | 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| Zimmer, Inc. | 510(k) number | 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| Zimmer, Inc. | 510(k) number | 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| Zimmer, Inc. | 510(k) number | 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| Zimmer, Inc. | 510(k) number | 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| Zimmer, Inc. | 510(k) number | 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-05-04 | Class II | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 1199 | 2017-07-05 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-05-04 | Class II | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 3893 | 2017-07-05 |
| Zimmer, Inc. | 510(k) number | 2016-02-11 | Class II | Under Investigation by firm | Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rathe | 9 units | 2016-12-01 |
| Zimmer, Inc. | 510(k) number | 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 4844 | 2017-05-23 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 209 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 87341 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 2 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 0 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 0 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 2236 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 17 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 30 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 2063 | 2017-04-13 |
| Zimmer, Inc. | 510(k) number | 2015-02-05 | Class II | Process control | PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating. | 1 unit | 2015-09-23 |
| Zimmer, Inc. | 510(k) number | 2014-12-17 | Class II | Package design/selection | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic inf | 1908 | 2015-09-23 |
| Zimmer Manufacturing B.V. | 510(k) number | 2014-12-04 | Class II | Under Investigation by firm | Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming | 68 units | 2015-06-18 |
| Zimmer Manufacturing B.V. | 510(k) number | 2014-11-21 | Class II | Equipment maintenance | Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. . | 6,377 | 2015-08-10 |
| Zimmer Manufacturing B.V. | 510(k) number | 2014-06-12 | Class II | Process design | Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labele | 496 | 2015-06-24 |
| Zimmer, Inc. | 510(k) number | 2014-05-23 | Class II | Packaging | Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. | 1487 units | 2015-03-06 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
Showing 40 of 63.
Recalls
29 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-09-26 | Class II | Labeling mix-ups | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and v | 72 units | |
| 2025-09-26 | Class II | Labeling mix-ups | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and v | 63 units | |
| 2020-08-14 | Class II | Under Investigation by firm | The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm. | 31 | 2022-06-09 |
| 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 294 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 138 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | 24 | 2020-05-28 | |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 665 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 101 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 510 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 96 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 84 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 182 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 1024 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 116 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 132 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 227 | 2020-05-28 |
| 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 58 | 2020-05-28 |
| 2018-01-03 | Class II | Labeling mix-ups | Two lots of hip implants are mislabeled. | 24 | 2019-04-11 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.