Plate, Fixation, Bone
ANKLE FIX compression/distraction instr.
22manufacturers in China registered for this device type
1,184catalogue numbers in this listing
32510(k) clearances naming this product code
30recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K040593 |
| Record published | 2015-09-24 |
| Record revised | 2025-02-06 (version 9) |
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, manufacturing date |
| Sizes | Length 6 to 400 mm; outer diameter 1 to 7 mm; height 1.5 to 2 mm; angle 10 ° |
| Distribution end date | 2021-12-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 47-2358-014-08 | Length 96 mm | In distribution | |
| 47-2359-018-38 | Length 18 mm | In distribution | |
| 47-2328-051-05 | 5 Hole | In distribution | |
| 2358-13-08 | Length 96 mm | In distribution | |
| 2359-22-45 | Length 22 mm | In distribution | |
| 00-4946-007-07 | Length 92 mm | In distribution | |
| 2359-80-56 | 5.5 mm Cannulated Conical Screw | In distribution | |
| 47-4840-070-00 | Length 70 mm | In distribution | |
| 2357-08-10 | Length 168 mm | In distribution | |
| 28.30.118 | Length 18 mm | In distribution | |
| 47-4815-010-03 | Length 10 mm | In distribution | |
| 47-4946-004-03 | 4 Holes | In distribution | |
| 00-4938-016-07 | 2.7 mm Locking Dual Compression Plate, 16 Holes | In distribution | |
| 47-4936-005-07 | 3.5 mm, 5 Holes | In distribution | |
| 47-4835-016-04 | Length 16 mm | In distribution | |
| 2359-70-55 | 5.5 mm Cannulated Locking Screw | In distribution | |
| 00-4928-018-02 | 2.7 mm Locking L-Plate, 5 Hole-Shaft | In distribution | |
| 47-2328-061-03 | In distribution | ||
| 28.07.108 | 8-hole, T-shape, right, Sys 2.7 | In distribution | |
| 47-4938-006-07 | 2.7 mm, 6 Holes | In distribution | |
| 2359-55-56 | 5.5 mm Cannulated Conical Screw | In distribution | |
| 47-4845-040-01 | Length 40 mm | In distribution | |
| 47-4946-013-13 | Length 170 mm | In distribution | |
| 2358-25-06 | Length 95 mm | In distribution | |
| 00-4928-008-07 | Length 95 mm | In distribution | |
| 00-2359-024-26 | Length 24 mm | In distribution | |
| 47-4946-003-13 | 3.5 mm Locking Reconstruction Plate, 3 Holes | In distribution | |
| 503004047 | for 3.2 drill, Sys 4.0 | In distribution | |
| 00-2359-046-38 | Length 46 mm | In distribution | |
| 28.25.108 | TX8 | In distribution | |
| 00-4938-007-03 | Length 82 mm | In distribution | |
| 2359-70-36 | 3.5 mm Cannulated Locking Screw | In distribution | |
| 47-2359-036-45 | 4.5 mm, Locking Screw | In distribution | |
| 6500-07-028 | Length 28 mm | In distribution | |
| 47-4820-026-02 | 2.0 mm, Cortical Screw | In distribution | |
| 28.22.038 | HEX | In distribution | |
| 00-4938-005-02 | Length 62 mm | In distribution | |
| 47-4936-012-03 | Length 159 mm | In distribution | |
| 47-4946-020-07 | 3.5 mm, 20 Holes | In distribution | |
| 47-4938-007-07 | Length 84 mm | In distribution | |
| 47-4928-009-02 | 2.7 mm Locking L-Plate, 3 Hole-Shaft | In distribution | |
| 2358-13-10 | Length 118 mm | In distribution | |
| 22.27.611 | Length 100 mm | 6 | In distribution |
| 47-2359-030-27 | 2.7 mm, Locking Screw | In distribution | |
| 47-2359-050-35 | Length 50 mm | In distribution | |
| 28.30.150 | Length 50 mm | In distribution | |
| 2359-60-36 | Length 60 mm | In distribution | |
| 47-2359-040-27 | 2.7 mm, Locking Screw | In distribution | |
| 47-4946-014-07 | Length 183 mm | In distribution | |
| 00-2357-017-04 | Length 80 mm | In distribution | |
| 2358-22-08 | Length 98 mm | In distribution | |
| 2359-38-35 | Length 38 mm | In distribution | |
| 28.14.000 | In distribution | ||
| 00-4938-010-07 | Length 118 mm | In distribution | |
| 2359-70-56 | 5.5 mm Cannulated Conical Screw | In distribution | |
| 47-2358-005-03 | Length 72 mm | In distribution | |
| 47-4827-034-01 | Length 34 mm | In distribution | |
| 00-2358-107-07 | Length 126 mm | In distribution | |
| 4845-60-01 | Length 60 mm | In distribution | |
| 00-2360-102-02 | In distribution | ||
| 00-2366-099-01 | In distribution | ||
| 00-4928-012-13 | Length 97 mm | In distribution | |
| 47-4928-008-02 | Length 39 mm | In distribution | |
| 47-4938-003-03 | 3 Holes | In distribution | |
| 47-2358-028-05 | Length 51 mm | In distribution | |
| 47-2359-022-18 | Length 22 mm | In distribution | |
| 2359-40-37 | 3.5 mm Cannulated Conical Screw | In distribution | |
| 00-4928-014-13 | Length 113 mm | In distribution | |
| 47-4820-042-00 | Length 42 mm | In distribution | |
| 28.21.020 | Outer Diameter 2.7 mm | In distribution | |
| 47-4928-008-03 | Length 93 mm | In distribution | |
| 28.20.032 | HEX | In distribution | |
| 28.20.130 | HEX | In distribution | |
| 605160231 | Outer Diameter 1.6 mm | 10 | In distribution |
| 28.21.036 | TX8 | In distribution | |
| 2359-65-56 | Length 65 mm | In distribution | |
| 47-2359-058-27 | 2.7 mm, Locking Screw | In distribution | |
| 47-4820-018-03 | Length 18 mm | In distribution | |
| 47-2359-022-24 | 2.4 mm, Locking Screw | In distribution | |
| 28.21.034 | TX8 | In distribution | |
| 2358-21-12 | Length 139 mm | In distribution | |
| 47-4946-006-03 | Length 81 mm | In distribution | |
| 47-4840-036-00 | 4.0 mm, Cancellous Screw | In distribution | |
| 2358-26-01 | Length 40 mm | In distribution | |
| 28.30.142 | Length 42 mm | In distribution | |
| 47-2357-010-10 | 10 Holes | In distribution | |
| 28.22.128 | Length 28 mm | In distribution | |
| 6500-07-024 | Length 24 mm | In distribution | |
| 47-2358-008-03 | Length 78 mm | In distribution | |
| 2359-16-27 | 2.7 mm Locking Screw | In distribution | |
| 47-4835-018-04 | 3.5 mm, Shaft Screw | In distribution | |
| 47-4938-007-02 | Length 39 mm | In distribution | |
| 47-2359-010-24 | 2.4 mm, Locking Screw | In distribution | |
| 47-4820-028-00 | 2.0 mm, Cortical Screw | In distribution | |
| 47-4936-033-05 | 3.5 mm Locking T-Plate, 3 Hole-Head, 3 Hole-Shaft | In distribution | |
| 47-4827-014-01 | 2.7 mm, Cortical Screw | In distribution | |
| 47-4936-015-13 | 3.5 mm Locking Reconstruction Plate, 15 Holes | In distribution | |
| 00-2359-018-38 | 3.5 mm Locking Screw With 2.7 mm Head | In distribution | |
| 47-4928-007-07 | Length 84 mm | In distribution | |
| 47-4840-012-01 | 4.0 mm, Cancellous Screw | In distribution | |
| 47-4946-035-04 | 3.5 mm Locking T-Plate, 3 Hole-Head, 5 Hole-Shaft | In distribution | |
| 47-4946-009-13 | 3.5 mm Locking Reconstruction Plate, 9 Holes | In distribution | |
| 47-4815-014-02 | Length 14 mm | In distribution | |
| 47-4840-085-00 | 4.0 mm, Cancellous Screw | In distribution | |
| 2360-94-02 | In distribution | ||
| 47-4946-014-13 | 3.5 mm Locking Reconstruction Plate, 14 Holes | In distribution | |
| 28.30.146 | Length 46 mm | In distribution | |
| 47-4928-016-13 | 2.7 mm, 16 Holes | In distribution | |
| 47-2357-101-06 | 6 Holes | In distribution | |
| 00-4938-004-03 | 4 Holes | In distribution | |
| 00-4946-008-13 | Length 105 mm | In distribution | |
| 2359-30-35 | Length 30 mm | In distribution | |
| 47-2358-021-08 | 8 Holes | In distribution | |
| 28.30.030 | Length 30 mm | In distribution | |
| 00-2328-075-05 | In distribution | ||
| 00-4928-010-07 | Length 118 mm | In distribution | |
| 47-4827-006-01 | 2.7 mm, Cortical Screw | In distribution | |
| 2357-07-18 | Length 264 mm | In distribution | |
| 47-2357-007-06 | Length 120 mm | In distribution | |
| 47-4835-032-01 | 3.5 mm, Cortical Screw | In distribution | |
| 2358-21-10 | Length 119 mm | In distribution | |
| 28.07.106 | 6-hole, T-shape, straight, Sys 2.7 | In distribution | |
| 00-4938-008-02 | Length 39 mm | In distribution | |
| 47-2358-001-04 | 4 Holes | In distribution | |
| 47-4938-014-13 | Length 113 mm | In distribution | |
| 00-2359-008-38 | 3.5 mm Locking Screw with 2.7 mm Head | In distribution | |
| 47-4840-050-01 | Length 50 mm | In distribution | |
| 00-2328-061-03 | In distribution | ||
| 47-4938-007-03 | Length 82 mm | In distribution | |
| 47-4936-005-13 | 3.5 mm Locking Reconstruction Plate, 5 Holes | In distribution | |
| 47-4815-018-03 | 1.5 mm, Cortical Screw | In distribution | |
| 47-4827-046-01 | Length 46 mm | In distribution | |
| 00-4946-003-13 | Length 40 mm | In distribution | |
| 47-2358-012-13 | 13 Holes | In distribution | |
| 00-4938-019-02 | Length 65 mm | In distribution | |
| 47-4845-030-04 | 4.5 mm, Shaft Screw | In distribution | |
| 47-2358-009-05 | 5 Holes | In distribution | |
| 47-4835-065-00 | 3.5 mm, Cortical Screw | In distribution | |
| 28.01.012 | Sys 3.5 | In distribution | |
| 47-2357-005-18 | 5.5 mm Proximal Lateral Tibial Plate, 18 Holes | In distribution | |
| 47-4827-040-01 | 2.7 mm, Cortical Screw | In distribution | |
| 00-4928-004-02 | Length 39 mm | In distribution | |
| 00-4946-004-07 | 3.5 mm Locking Dual Compression Plate, 4 Holes | In distribution | |
| 47-2359-036-27 | Length 36 mm | In distribution | |
| 47-2357-006-18 | 5.5 mm Proximal Lateral Tibial Plate, 18 Holes | In distribution | |
| 4845-68 | 4.5 mm Cortical Screw | In distribution | |
| 47-2359-016-35 | 3.5 mm, Locking Screw | In distribution | |
| 00-4938-004-07 | Length 49 mm | In distribution | |
| 28.20.050 | Length 50 mm | In distribution | |
| 2358-02-12 | 12 Holes | In distribution | |
| 4845-55-08 | Length 55 mm | In distribution | |
| 47-2359-012-35 | 3.5 mm, Locking Screw | In distribution | |
| 47-4928-010-07 | Length 118 mm | In distribution | |
| 47-4938-006-03 | Length 70 mm | In distribution | |
| 2360-93-06 | 3.5 mm Proximal Lateral Tibial Jig | In distribution | |
| 4845-48-01 | Length 48 mm | In distribution | |
| 47-4827-012-01 | 2.7 mm, Cortical Screw | In distribution | |
| 47-4865-030-01 | Length 30 mm | In distribution | |
| 4845-45-08 | 4.5 mm Malleolar Screw | In distribution | |
| 47-4815-008-00 | Length 8 mm | In distribution | |
| 00-2366-085-00 | 1.25 mm Diameter | 3 | In distribution |
| 47-2328-053-05 | 5 Hole | In distribution | |
| 47-2358-009-07 | Length 129 mm | In distribution | |
| 00-4928-004-03 | Length 47 mm | In distribution | |
| 28.22.045 | HEX | In distribution | |
| 28.22.118 | Length 18 mm | In distribution | |
| 47-4835-032-04 | 3.5 mm, Shaft Screw | In distribution | |
| 28.25.122 | TX8 | In distribution | |
| 47-4827-018-01 | Length 18 mm | In distribution | |
| 47-2358-006-15 | 15 Holes | In distribution | |
| 47-4820-024-01 | 2.0 mm, Cortical Screw | In distribution | |
| 47-2328-052-13 | 13 Hole | In distribution | |
| 28.05.015 | Angle 10 ° | In distribution | |
| 47-4946-006-13 | Length 79 mm | In distribution | |
| 47-4938-010-13 | 2.7 mm, 10 Holes | In distribution | |
| 47-4827-030-01 | Length 30 mm | In distribution | |
| 28.25.118 | Length 18 mm | In distribution | |
| 2358-17-06 | Length 78 mm | In distribution | |
| 47-4827-065-01 | 2.7 mm, Cortical Screw | In distribution | |
| 00-2358-008-05 | Length 104 mm | In distribution | |
| 47-4820-046-03 | 2.0 mm, Cortical Screw | In distribution | |
| 47-4928-016-07 | 2.7 mm, 16 Holes | In distribution | |
| 47-2357-010-14 | Length 189 mm | In distribution | |
| 4845-64 | 4.5 mm Cortical Screw | In distribution | |
| 00-2358-012-03 | Length 77 mm | In distribution | |
| 47-2359-046-45 | 4.5 mm, Locking Screw | In distribution | |
| 47-4820-048-00 | 2.0 mm, Cortical Screw | In distribution | |
| 00-2328-052-05 | 5 Hole | In distribution | |
| 28.22.120 | Outer Diameter 3.5 mm | In distribution | |
| 47-4936-018-13 | 3.5 mm Locking Reconstruction Plate, 18 Holes | In distribution | |
| 00-4946-009-07 | 3.5 mm Locking Dual Compression Plate, 9 Holes | In distribution | |
| 47-2358-024-11 | Length 165 mm | In distribution | |
| 47-4938-017-02 | Length 62 mm | In distribution | |
| 47-2358-107-03 | 3 Holes | In distribution | |
| 47-2359-056-27 | 2.7 mm, Locking Screw | In distribution | |
| 47-4820-008-01 | 2.0 mm, Cortical Screw | In distribution | |
| 47-2359-060-35 | 3.5 mm, Locking Screw | In distribution | |
| 00-4946-034-06 | Length 63 mm | In distribution | |
| 47-2359-040-45 | 4.5 mm, Locking Screw | In distribution | |
| 28.01.404 | 4mm step, left, Sys 2.7 | In distribution | |
| 47-2358-002-12 | 12 Holes | In distribution | |
| 2359-28-27 | Length 28 mm | In distribution | |
| 6500-07-020 | Length 20 mm | In distribution | |
| 2359-42-35 | 3.5 mm Locking Screw | In distribution | |
| 2360-91-01 | 5.5 mm Proximal Lateral | In distribution | |
| 47-2359-052-27 | 2.7 mm, Locking Screw | In distribution | |
| 2358-14-02 | 2 Holes | In distribution | |
| 47-2359-050-56 | 5.5 mm, Cannulated Conical Screw | In distribution | |
| 4845-52-04 | Length 52 mm | In distribution | |
| 4845-52 | Length 52 mm | In distribution | |
| 47-4865-090-00 | 6.5 mm, Cancellous Screw | In distribution | |
| 00-4928-007-02 | 2.7 mm Locking L-Plate, 3 Hole-Shaft | In distribution | |
| 28.20.024 | Length 24 mm | In distribution | |
| 47-4820-016-02 | 2.0 mm, Cortical Screw | In distribution | |
| 47-2359-018-45 | Length 18 mm | In distribution | |
| 47-2359-008-25 | 2.4 mm, Conical Screw | In distribution | |
| 47-4946-005-13 | Length 66 mm | In distribution | |
| 2360-90-16 | In distribution | ||
| 00-2366-099-55 | In distribution | ||
| 00-2359-010-38 | 3.5 mm Locking Screw With 2.7 mm Head | In distribution | |
| 47-4820-006-01 | Length 6 mm | In distribution | |
| 4865-75-02 | Length 75 mm | In distribution | |
| 47-2328-060-03 | In distribution | ||
| 2359-50-27 | 2.7 mm Locking Screw | In distribution | |
| 00-4938-016-13 | Length 129 mm | In distribution | |
| 47-2359-075-35 | 3.5 mm, Locking Screw | In distribution | |
| 47-4936-005-03 | 5 Holes | In distribution | |
| 47-4936-008-13 | Length 105 mm | In distribution | |
| 00-4928-007-03 | 7 Holes | In distribution | |
| 47-4946-010-07 | Length 131 mm | In distribution | |
| 47-4845-042-01 | Length 42 mm | In distribution | |
| 2357-08-06 | 6 Holes | In distribution | |
| 47-4865-050-02 | 6.5 mm, Cancellous Screw, 32 mm Thread Length | In distribution | |
| 2359-30-27 | 2.7 mm Locking Screw | In distribution | |
| 47-4835-075-01 | 3.5 mm, Cortical Screw | In distribution | |
| 00-2366-080-00 | Length 102 mm | 3 | In distribution |
| 47-2358-014-03 | Length 39 mm | In distribution | |
| 47-4845-046-04 | 4.5 mm, Shaft Screw | In distribution | |
| 00-4928-005-02 | 2.7 mm Locking T-Plate, 2 Hole-Head, 5 Hole-Shaft | In distribution | |
| 2357-03-08 | 3.5 mm Proximal Lateral Tibial Plate, 8 Holes | In distribution | |
| 47-2359-038-27 | 2.7 mm, Locking Screw | In distribution | |
| 47-2358-005-09 | Length 150 mm | In distribution | |
| 47-4928-005-03 | 5 Holes | In distribution | |
| 47-2358-007-07 | Length 130 mm | In distribution | |
| 47-2359-012-26 | 2.7 mm, Conical Screw | In distribution | |
| 2360-92-02 | In distribution | ||
| 28.20.116 | Length 16 mm | In distribution | |
| 1179-13-12 | 2.7 mm Straight Recon Plate, 12 Holes | In distribution | |
| 2360-93-03 | In distribution | ||
| 1179-13-10 | 2.7 mm Straight Recon Plate, 10 Holes | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192217 | 2019-09-13 |
| K192021 | 2019-08-22 |
| K151716 | 2016-01-28 |
| K143331 | 2015-03-04 |
| K150121 | 2015-02-23 |
| K143066 | 2014-11-28 |
| K142836 | 2014-11-12 |
| K142579 | 2014-10-22 |
| K140508 | 2014-08-14 |
| K141517 | 2014-08-13 |
| K141734 | 2014-08-13 |
| K133246 | 2013-12-17 |
| K123918 | 2013-02-14 |
| K120772 | 2012-06-12 |
| K113718 | 2012-01-27 |
| K112174 | 2011-10-26 |
| K111039 | 2011-05-19 |
| K100111 | 2010-04-12 |
| K083654 | 2009-02-26 |
| K082527 | 2008-12-18 |
| K082078 | 2008-11-03 |
| K081759 | 2008-10-16 |
| K063303 | 2006-11-22 |
| K061211 | 2006-06-14 |
| K050121 | 2005-01-31 |
| K043560 | 2005-01-21 |
| K043227 | 2004-12-10 |
| K042695 | 2004-10-29 |
| K042598 | 2004-10-29 |
| K040593 | 2004-04-12 |
| K953714 | 1995-11-20 |
| K801603 | 1980-10-03 |
Recalls Naming This Product
56 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2023-06-27 | Class II | Process control | Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock. | 75 units | |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| 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. | 794 | 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. | 100 | 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. | 3955 | 2017-07-05 |
| 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. | 154 | 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. | 60 | 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. | 99 | 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. | 34 | 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. | 83 | 2017-04-13 |
| Zimmer, Inc. | 510(k) number | 2015-12-09 | Class II | Labeling Change Control | Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside | 400 | 2016-11-08 |
Showing 40 of 56.
Recalls
14 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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations faile | 972,125 units | 2015-09-15 |
| 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 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 95 | 2014-04-16 |
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 589 | 2014-04-16 |
| 2012-07-13 | Class II | Labeling mix-ups | Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws. | 24 to US Distributor with 7 further distributed | 2013-09-24 |
| 2008-06-09 | Not classified | Material/Component Contamination | An impurity in the metal may affect the strength of the plate or biocompatibility of the material with the body. | 7 | 2009-11-12 |
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.