Natural Nail®
552 catalogue numbers from 47-2491-320-14, listed by Zimmer, Inc., United States, under Rod, Fixation, Intramedullary And Accessories. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
552catalogue numbers in this listing
23510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| 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 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K083497 |
| Record published | 2015-09-17 |
| Record revised | 2026-02-09 (version 7) |
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 | Length 16 to 100 cm; length 20 to 508 mm; height 0 to 15 mm; outer diameter 4.3 to 13.5 mm; lumen/inner diameter 3 to 10.5 mm |
| Distribution end date | 2017-05-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47-2491-320-14 | 14 mm Diameter | In distribution |
| 47-2492-320-12 | 12 mm Diameter | In distribution |
| 00-2490-004-16 | In distribution | |
| 47-2492-421-09 | 9.3 mm Diameter | In distribution |
| 47-2483-090-50 | Length 90 mm | In distribution |
| 00-2490-098-10 | In distribution | |
| 47-2495-340-10 | 10 mm Diameter | In distribution |
| 47-2491-300-11 | 11 mm Diameter | In distribution |
| 47-2492-301-10 | 10 mm Diameter | In distribution |
| 00-2490-035-06 | 3.5 mm Hex | In distribution |
| 47-2495-300-13 | 13 mm Diameter | In distribution |
| 00-2490-004-00 | In distribution | |
| 00-2490-090-25 | 5/16 Inch Thread | In distribution |
| 00-2490-035-07 | 3.5 mm Hex | In distribution |
| 00-2490-005-20 | In distribution | |
| 47-2487-005-15 | Height 15 mm | In distribution |
| 47-2492-280-08 | 8.3 mm Diameter | In distribution |
| 47-2492-341-13 | Length 34 cm | In distribution |
| 47-2483-037-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2484-135-60 | Length 135 mm | In distribution |
| 47-2492-261-12 | 12 mm Diameter | In distribution |
| 47-2492-400-12 | Length 40 cm | In distribution |
| 00-2490-035-90 | In distribution | |
| 47-2483-085-40 | Length 85 mm | In distribution |
| 47-2492-401-11 | Length 40 cm | In distribution |
| 47-2495-240-10 | Length 24 cm | In distribution |
| 00-2490-032-80 | In distribution | |
| 47-2495-340-08 | 8.3 mm Diameter | In distribution |
| 47-2484-115-60 | 6.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2484-022-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2495-340-11 | 11 mm Diameter | In distribution |
| 00-2490-014-15 | 15.5 mm | In distribution |
| 47-2495-380-13 | 13 mm Diameter | In distribution |
| 47-2484-052-50 | Length 52.5 mm | In distribution |
| 47-2487-005-05 | Height 5 mm | In distribution |
| 47-2483-055-60 | 6.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2484-030-50 | Length 30 mm | In distribution |
| 47-2494-300-10 | 10 mm Diameter | In distribution |
| 47-2494-200-10 | Length 20 cm | In distribution |
| 47-2490-097-00 | 3.0 mm Diameter | In distribution |
| 47-2492-321-12 | 12 mm Diameter | In distribution |
| 47-2484-025-50 | Length 25 mm | In distribution |
| 47-2492-361-14 | Length 36 cm | In distribution |
| 47-2483-057-40 | Length 57.5 mm | In distribution |
| 47-2483-050-60 | Length 50 mm | In distribution |
| 47-2483-027-50 | Length 27.5 mm | In distribution |
| 47-2494-160-10 | 10 mm Diameter | In distribution |
| 47-2492-281-13 | 13 mm Diameter | In distribution |
| 00-2490-065-49 | Lumen/Inner Diameter 4.9 mm | In distribution |
| 47-2484-130-60 | 6.0 mm Diameter, 3.5 mm Hex Head | In distribution |
| 47-2495-240-12 | Length 24 cm | In distribution |
| 47-2492-380-13 | 13 mm Diameter | In distribution |
| 47-2494-420-10 | Length 42 cm | In distribution |
| 47-2484-080-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2491-440-11 | 11 mm Diameter | In distribution |
| 47-2492-340-10 | 10 mm Diameter | In distribution |
| 47-2483-105-60 | 6.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 00-2490-065-85 | Outer Diameter 8 mm | In distribution |
| 47-2491-460-10 | Length 46 cm | In distribution |
| 47-2492-321-13 | 13 mm Diameter | In distribution |
| 47-2495-340-12 | Length 34 cm | In distribution |
| 47-2483-050-50 | Length 50 mm | In distribution |
| 47-2484-070-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2484-025-40 | Length 25 mm | In distribution |
| 47-2491-320-10 | Length 32 cm | In distribution |
| 47-2492-320-08 | Length 32 cm | In distribution |
| 47-2484-070-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2491-420-11 | Length 42 cm | In distribution |
| 47-2484-027-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2492-320-09 | 9.3 mm Diameter | In distribution |
| 47-2483-052-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2484-075-50 | Length 75 mm | In distribution |
| 47-2495-340-14 | 14 mm Diameter | In distribution |
| 47-2492-401-13 | Length 40 cm | In distribution |
| 47-2494-240-11 | 11.5 mm Diameter | In distribution |
| 47-2483-100-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 00-2490-003-44 | In distribution | |
| 47-2487-001-10 | Height 10 mm | In distribution |
| 47-2495-260-13 | 13 mm Diameter | In distribution |
| 47-2495-320-10 | 10 mm Diameter | In distribution |
| 47-2495-400-14 | 14 mm Diameter | In distribution |
| 47-2495-400-11 | 11 mm Diameter | In distribution |
| 00-2490-014-04 | 15.5 mm Diameter | In distribution |
| 47-2484-050-60 | Length 50 mm | In distribution |
| 47-2492-340-14 | Length 34 cm | In distribution |
| 47-2491-320-12 | 12 mm Diameter | In distribution |
| 47-2484-060-50 | Length 60 mm | In distribution |
| 00-2490-014-03 | In distribution | |
| 00-2490-081-80 | Lumen/Inner Diameter 8 mm | In distribution |
| 47-2495-420-12 | 12 mm Diameter | In distribution |
| 47-2491-300-12 | Length 30 cm | In distribution |
| 47-2488-000-01 | 11 mm Diameter | In distribution |
| 47-2492-281-12 | 12 mm Diameter | In distribution |
| 00-2490-004-22 | In distribution | |
| 47-2491-380-10 | Length 38 cm | In distribution |
| 47-2495-320-12 | 12 mm Diameter | In distribution |
| 47-2495-440-13 | 13 mm Diameter | In distribution |
| 47-2492-380-11 | Length 38 cm | In distribution |
| 47-2491-380-12 | 12 mm Diameter | In distribution |
| 47-2483-042-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2492-341-08 | 8.3 mm Diameter | In distribution |
| 47-2495-360-12 | Length 36 cm | In distribution |
| 47-2483-115-60 | 6.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2491-360-11 | Length 36 cm | In distribution |
| 47-2484-075-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2492-360-14 | Length 36 cm | In distribution |
| 47-2494-320-13 | 13 mm Diameter | In distribution |
| 47-2487-002-15 | Height 15 mm | In distribution |
| 47-2494-380-13 | Length 38 cm | In distribution |
| 47-2494-360-13 | 13 mm Diameter | In distribution |
| 00-2490-042-10 | 8.0 mm Diameter | In distribution |
| 47-2483-022-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2492-321-14 | 14 mm Diameter | In distribution |
| 47-2492-340-12 | 12 mm Diameter | In distribution |
| 47-2484-065-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2492-301-12 | Length 30 cm | In distribution |
| 47-2483-080-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2484-110-60 | 6.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 00-2490-048-32 | 3.2 mm Diameter | In distribution |
| 00-2490-035-03 | 3.5 mm Hex | In distribution |
| 47-2494-200-13 | 13 mm Diameter | In distribution |
| 47-2491-300-09 | Length 30 cm | In distribution |
| 00-2490-063-40 | Lumen/Inner Diameter 3 mm | In distribution |
| 47-2495-240-14 | Length 24 cm | In distribution |
| 47-2491-340-09 | 9.3 mm Diameter | In distribution |
| 47-2483-075-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2491-320-13 | 13 mm Diameter | In distribution |
| 47-2494-440-11 | Length 44 cm | In distribution |
| 47-2495-240-11 | Length 24 cm | In distribution |
| 47-2484-035-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 00-2490-003-50 | In distribution | |
| 47-2492-300-12 | 12 mm Diameter | In distribution |
| 47-2491-400-10 | 10 mm Diameter | In distribution |
| 47-2491-340-14 | 14 mm Diameter | In distribution |
| 47-2484-035-60 | Length 35 mm | In distribution |
| 47-2495-440-14 | 14 mm Diameter | In distribution |
| 47-2492-461-09 | 9.3 mm Diameter | In distribution |
| 47-2492-301-14 | Length 30 cm | In distribution |
| 47-2492-321-09 | Length 32 cm | In distribution |
| 47-2495-360-10 | Length 36 cm | In distribution |
| 47-2495-420-14 | 14 mm Diameter | In distribution |
| 47-2495-440-11 | Length 44 cm | In distribution |
| 47-2484-120-60 | Length 120 mm | In distribution |
| 47-2492-280-13 | 13 mm Diameter | In distribution |
| 47-2492-401-12 | Length 40 cm | In distribution |
| 47-2488-000-01 | 11 mm Diameter | In distribution |
| 00-2490-003-51 | In distribution | |
| 47-2483-050-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2495-420-10 | 10 mm Diameter | In distribution |
| 47-2483-045-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2484-020-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 00-2490-090-11 | M11 Thread | In distribution |
| 47-2494-420-11 | Length 42 cm | In distribution |
| 00-2490-008-01 | In distribution | |
| 47-2491-460-12 | Length 46 cm | In distribution |
| 47-2492-380-10 | 10 mm Diameter | In distribution |
| 47-2492-300-11 | Length 30 cm | In distribution |
| 47-2492-361-11 | Length 36 cm | In distribution |
| 47-2491-400-14 | Length 40 cm | In distribution |
| 47-2494-380-11 | 11.5 mm Diameter | In distribution |
| 47-2491-360-14 | Length 36 cm | In distribution |
| 47-2483-065-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2483-035-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2492-300-09 | Length 30 cm | In distribution |
| 47-2490-030-14 | 3.0 mm Diameter | In distribution |
| 47-2483-085-50 | Length 85 mm | In distribution |
| 47-2491-440-10 | Length 44 cm | In distribution |
| 47-2495-400-10 | Length 40 cm | In distribution |
| 47-2483-057-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2484-085-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2495-280-12 | 12 mm Diameter | In distribution |
| 47-2492-321-08 | Length 32 cm | In distribution |
| 47-2495-320-08 | Length 32 cm | In distribution |
| 47-2484-055-50 | Length 55 mm | In distribution |
| 47-2492-441-13 | Length 44 cm | In distribution |
| 47-2492-401-08 | Length 40 cm | In distribution |
| 47-2483-120-60 | 6.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2492-381-13 | Length 38 cm | In distribution |
| 47-2492-460-09 | Length 46 cm | In distribution |
| 47-2487-008-15 | Height 15 mm | In distribution |
| 47-2495-320-11 | Length 32 cm | In distribution |
| 00-2490-047-32 | Length 508 mm | In distribution |
| 00-2490-003-52 | In distribution | |
| 47-2492-320-14 | 14 mm Diameter | In distribution |
| 47-2495-300-14 | Length 30 cm | In distribution |
| 47-2484-057-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2494-400-13 | 13 mm Diameter | In distribution |
| 47-2492-441-11 | 11 mm Diameter | In distribution |
| 47-2494-400-11 | 11.5 mm Diameter | In distribution |
| 47-2484-030-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2483-065-40 | Length 65 mm | In distribution |
| 47-2491-380-09 | 9.3 mm Diameter | In distribution |
| 47-2492-401-10 | 10 mm Diameter | In distribution |
| 47-2492-461-10 | 10 mm Diameter | In distribution |
| 00-2490-091-11 | In distribution | |
| 47-2495-280-11 | 11 mm Diameter | In distribution |
| 47-2495-300-11 | 11 mm Diameter | In distribution |
| 47-2491-440-13 | 13 mm Diameter | In distribution |
| 47-2494-360-11 | 11.5 mm Diameter | In distribution |
| 47-2483-045-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2495-360-11 | 11 mm Diameter | In distribution |
| 47-2492-461-13 | 13 mm Diameter | In distribution |
| 47-2491-360-12 | 12 mm Diameter | In distribution |
| 47-2491-460-14 | 14 mm Diameter | In distribution |
| 47-2494-380-10 | 10 mm Diameter | In distribution |
| 47-2483-060-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2492-420-10 | 10 mm Diameter | In distribution |
| 47-2492-300-14 | 14 mm Diameter | In distribution |
| 00-2490-041-04 | In distribution | |
| 47-2483-032-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2484-100-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2492-341-09 | 9.3 mm Diameter | In distribution |
| 47-2495-440-09 | 9.3 mm Diameter | In distribution |
| 47-2495-400-13 | Length 40 cm | In distribution |
| 47-2483-047-50 | Length 47.5 mm | In distribution |
| 47-2484-065-60 | Length 65 mm | In distribution |
| 47-2487-008-00 | Height 0 mm | In distribution |
| 47-2492-281-11 | 11 mm Diameter | In distribution |
| 47-2492-280-14 | Length 28 cm | In distribution |
| 47-2494-320-10 | 10 mm Diameter | In distribution |
| 00-2490-003-00 | In distribution | |
| 47-2495-260-08 | 8.3 mm Diameter | In distribution |
| 47-2491-340-12 | 12 mm Diameter | In distribution |
| 47-2487-001-15 | Height 15 mm | In distribution |
| 47-2484-057-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2492-441-10 | 10 mm Diameter | In distribution |
| 00-2490-071-80 | Lumen/Inner Diameter 8 mm | In distribution |
| 47-2487-008-10 | Height 10 mm | In distribution |
| 47-2491-340-13 | 13 mm Diameter | In distribution |
| 47-2492-460-13 | 13 mm Diameter | In distribution |
| 47-2492-300-08 | 8.3 mm Diameter | In distribution |
| 47-2484-040-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2494-160-13 | 13 mm Diameter | In distribution |
| 47-2484-022-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2484-080-60 | Length 80 mm | In distribution |
| 47-2491-400-13 | Length 40 cm | In distribution |
| 47-2495-300-12 | Length 30 cm | In distribution |
| 47-2484-042-50 | 5.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
| 47-2495-420-11 | Length 42 cm | In distribution |
| 47-2492-341-10 | 10 mm Diameter | In distribution |
| 47-2483-040-40 | Length 40 mm | In distribution |
| 47-2484-125-60 | Length 125 mm | In distribution |
| 47-2492-260-11 | Length 26 cm | In distribution |
| 47-2492-380-09 | 9.3 mm Diameter | In distribution |
| 47-2492-461-12 | Length 46 cm | In distribution |
| 47-2495-280-10 | 10 mm Diameter | In distribution |
| 47-2483-055-40 | Length 55 mm | In distribution |
| 47-2492-260-08 | Length 26 cm | In distribution |
| 47-2483-027-40 | Length 27.5 mm | In distribution |
| 47-2483-032-40 | 4.0 mm, Diameter, 3.5 mm Hex Head | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Precice® Bone Transport System | NuVasive Specialized Orthopedics, Inc. | 546 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253566 | 2026-03-12 |
| K243907 | 2025-02-12 |
| K241651 | 2024-09-26 |
| K200814 | 2020-04-28 |
| K192312 | 2019-10-11 |
| K191238 | 2019-07-05 |
| K181827 | 2018-12-14 |
| K172114 | 2017-08-10 |
| K143321 | 2015-05-29 |
| K142281 | 2014-10-22 |
| K130595 | 2013-09-17 |
| K120715 | 2012-08-10 |
| K101622 | 2010-10-01 |
| K091566 | 2009-10-28 |
| K090596 | 2009-06-30 |
| K083497 | 2009-02-19 |
| K082770 | 2008-12-11 |
| K043270 | 2005-01-31 |
| K032367 | 2003-08-12 |
| K972692 | 1997-09-19 |
| K965098 | 1997-02-28 |
| K962561 | 1996-09-25 |
| K853250 | 1986-02-12 |
Recalls Naming This Product
27 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 | 2021-05-07 | Class II | Process design | Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree | 8 units | 2024-04-18 |
| Zimmer, Inc. | 510(k) number | 2021-05-07 | Class II | Process design | Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree | 16 units | 2024-04-18 |
| 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 | 2018-07-30 | Class II | Mixed-up of materials/components | The item is labeled as an 8.3mm, but it is actually a 12 mm. | 1 unit | 2019-10-24 |
| Zimmer, Inc. | 510(k) number | 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19483 total products | 2020-11-18 |
| Zimmer, Inc. | 510(k) number | 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19483 total products | 2020-11-18 |
| Zimmer, Inc. | 510(k) number | 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19483 total products | 2020-11-18 |
| Zimmer, Inc. | 510(k) number | 2017-04-28 | Class II | Under Investigation by firm | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. | 1707 | 2019-05-15 |
| Zimmer, Inc. | 510(k) number | 2015-09-03 | Class II | Package design/selection | In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or dur | 57,603 units | 2016-03-15 |
| Zimmer, Inc. | 510(k) number | 2015-06-17 | Class II | Process control | A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure | 8 | 2016-03-15 |
| Zimmer, Inc. | 510(k) number | 2013-11-05 | Class II | Process change control | Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements fo | 42, 065 units total | 2015-05-05 |
| Zimmer, Inc. | 510(k) number | 2013-11-05 | Class II | Process change control | Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements fo | 42, 065 units total | 2015-05-05 |
| Zimmer, Inc. | 510(k) number | 2010-10-29 | Not classified | Nonconforming Material/Component | The firm has determined that two lots of this instrument were inappropriately manufactured by the supplier. The manufacturing process created a step in the lumen which impedes the Lag Screw Retaining Shaft from passing through the lumen wi | 34 | 2011-09-16 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
| Zimmer, Inc. | 510(k) number | 2009-07-01 | Not classified | Other | The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the | 327 of total product | 2011-10-05 |
Recalls
32 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 |
|---|---|---|---|---|---|
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 24 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 22 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 24 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 23 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 22 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 11 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 22 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 24 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 22 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 23 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 3 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 22 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 23 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 24 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 24 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 23 | |
| 2025-12-02 | Class II | Process design | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non | 11 | |
| 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 |
| 2017-04-28 | Class II | Under Investigation by firm | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. | 1499 | 2019-05-15 |
| 2017-04-28 | Class II | Under Investigation by firm | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. | 27279 | 2019-05-15 |
| 2017-04-28 | Class II | Under Investigation by firm | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. | 24969 | 2019-05-15 |
| 2017-04-28 | Class II | Under Investigation by firm | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. | 3856 | 2019-05-15 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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.