Itst®
179 catalogue numbers from 2257-440-10, 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
179catalogue 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) | K032367 |
| Record published | 2015-09-24 |
| 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 18 to 50 cm; length 60 to 120 mm |
| Distribution end date | 2017-05-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2257-440-10 | Length 44 cm | In distribution |
| 2259-09-10 | 10 mm Head Height | In distribution |
| 2257-380-01 | Length 38 cm | In distribution |
| 2257-360-11 | Length 36 cm | In distribution |
| 2259-01-45 | 11 mm Diameter | In distribution |
| 2256-180-15 | Length 18 cm | In distribution |
| 2257-180-15 | 15 mm, Diameter | In distribution |
| 2257-85-65 | 6.5 mm Diameter | In distribution |
| 2259-01-40 | Length 95 mm | In distribution |
| 2257-420-11 | 11 mm, Diameter | In distribution |
| 2257-180-13 | Length 18 cm | In distribution |
| 2257-460-13 | 13 mm, Diameter | In distribution |
| 00-2258-087-01 | In distribution | |
| 2257-340-12 | 12 mm, Diameter | In distribution |
| 2257-440-02 | 12 mm, Diameter | In distribution |
| 2257-500-12 | 12 mm, Diameter | In distribution |
| 2257-460-04 | Length 46 cm | In distribution |
| 2257-360-03 | 13 mm, Diameter | In distribution |
| 2257-500-13 | 13 mm, Diameter | In distribution |
| 2257-480-03 | 13 mm, Diameter | In distribution |
| 2257-400-10 | Length 40 cm | In distribution |
| 2257-420-03 | 13 mm, Diameter | In distribution |
| 2257-380-04 | 14 mm, Diameter | In distribution |
| 2257-460-12 | Length 46 cm | In distribution |
| 2257-380-10 | 10 mm, Diameter | In distribution |
| 2257-400-12 | Length 40 cm | In distribution |
| 2257-480-01 | Length 48 cm | In distribution |
| 2257-300-13 | Length 30 cm | In distribution |
| 2256-02-32 | Length 80 mm | In distribution |
| 2257-320-12 | 12 mm, Diameter | In distribution |
| 2256-02-40 | Length 95 mm | In distribution |
| 2257-440-12 | Length 44 cm | In distribution |
| 2257-400-01 | Length 40 cm | In distribution |
| 2257-440-01 | 11 mm, Diameter | In distribution |
| 2257-340-00 | Length 34 cm | In distribution |
| 2259-08-05 | 5 mm Head Height | In distribution |
| 2259-01-27 | Length 70 mm | In distribution |
| 2259-01-42 | Length 100 mm | In distribution |
| 2257-110-65 | Length 110 mm | In distribution |
| 2257-380-12 | 12 mm, Diameter | In distribution |
| 2257-360-01 | Length 36 cm | In distribution |
| 2257-360-02 | 12 mm, Diameter | In distribution |
| 2257-400-11 | Length 40 cm | In distribution |
| 2257-100-65 | Length 100 mm | In distribution |
| 2257-460-14 | Length 46 cm | In distribution |
| 2256-02-30 | 11 mm Diameter | In distribution |
| 2257-300-03 | Length 30 cm | In distribution |
| 2256-02-45 | Length 105 mm | In distribution |
| 2257-440-04 | Length 44 cm | In distribution |
| 2257-480-04 | 14 mm, Diameter | In distribution |
| 2257-360-10 | 10 mm, Diameter | In distribution |
| 2257-500-00 | Length 50 cm | In distribution |
| 2257-180-12 | Length 18 cm | In distribution |
| 2259-08 | 0 mm Head Height | In distribution |
| 2257-380-14 | 14 mm, Diameter | In distribution |
| 2257-440-13 | Length 44 cm | In distribution |
| 2257-300-12 | 12 mm, Diameter | In distribution |
| 2257-320-14 | 14 mm, Diameter | In distribution |
| 2257-360-12 | 12 mm, Diameter | In distribution |
| 2257-500-10 | 10 mm, Diameter | In distribution |
| 00-2258-052-03 | In distribution | |
| 2257-420-04 | 14 mm, Diameter | In distribution |
| 00-2258-053-01 | In distribution | |
| 2259-08-10 | 10 mm Head Height | In distribution |
| 2257-360-00 | Length 36 cm | In distribution |
| 2257-340-14 | 14 mm, Diameter | In distribution |
| 2257-95-65 | 6.5 mm Diameter | In distribution |
| 2257-420-12 | Length 42 cm | In distribution |
| 2257-420-02 | Length 42 cm | In distribution |
| 2257-320-00 | 10 mm, Diameter | In distribution |
| 2259-01-50 | Length 115 mm | In distribution |
| 2257-360-14 | Length 36 cm | In distribution |
| 2257-420-01 | 11 mm, Diameter | In distribution |
| 2259-01-47 | 11 mm Diameter | In distribution |
| 2257-180-10 | 10 mm, Diameter | In distribution |
| 2256-02-50 | Length 115 mm | In distribution |
| 2259-09 | 0 mm Head Height | In distribution |
| 2257-480-11 | 11 mm, Diameter | In distribution |
| 2256-02-37 | Length 90 mm | In distribution |
| 2257-420-13 | Length 42 cm | In distribution |
| 2257-180-11 | 11 mm, Diameter | In distribution |
| 2257-320-13 | Length 32 cm | In distribution |
| 2257-460-03 | Length 46 cm | In distribution |
| 2257-300-01 | 11 mm, Diameter | In distribution |
| 00-2258-052-04 | In distribution | |
| 2256-02-47 | 11 mm Diameter | In distribution |
| 2257-320-04 | Length 32 cm | In distribution |
| 2257-400-14 | Length 40 cm | In distribution |
| 2257-440-11 | Length 44 cm | In distribution |
| 2257-320-02 | Length 32 cm | In distribution |
| 2257-500-01 | 11 mm, Diameter | In distribution |
| 2257-300-04 | Length 30 cm | In distribution |
| 2257-320-10 | 10 mm, Diameter | In distribution |
| 2257-500-04 | 14 mm, Diameter | In distribution |
| 2257-90-65 | Length 90 mm | In distribution |
| 2257-420-00 | 10 mm, Diameter | In distribution |
| 2257-460-11 | Length 46 cm | In distribution |
| 2259-09-15 | 15 mm Head Height | In distribution |
| 2256-180-11 | 11 mm, Diameter | In distribution |
| 2257-440-14 | 14 mm, Diameter | In distribution |
| 2257-500-11 | Length 50 cm | In distribution |
| 2257-340-13 | 13 mm, Diameter | In distribution |
| 2259-09-20 | 20 mm Head Height | In distribution |
| 2257-300-14 | 14 mm, Diameter | In distribution |
| 2259-07-20 | 20 mm Head Height | In distribution |
| 2257-380-02 | Length 38 cm | In distribution |
| 2259-08-15 | 15 mm Head Height | In distribution |
| 2257-440-00 | 10 mm, Diameter | In distribution |
| 2256-02-35 | Length 85 mm | In distribution |
| 2257-460-00 | 10 mm, Diameter | In distribution |
| 2256-180-12 | Length 18 cm | In distribution |
| 2257-300-02 | Length 30 cm | In distribution |
| 2259-07 | 0 mm Head Height | In distribution |
| 2257-380-00 | Length 38 cm | In distribution |
| 2259-07-10 | 10 mm Head Height | In distribution |
| 2257-340-02 | 12 mm, Diameter | In distribution |
| 2259-07-15 | 15 mm Head Height | In distribution |
| 2256-02-27 | Length 70 mm | In distribution |
| 2257-500-14 | Length 50 cm | In distribution |
| 2257-300-11 | 11 mm, Diameter | In distribution |
| 2257-320-03 | 13 mm, Diameter | In distribution |
| 2257-300-00 | 10 mm, Diameter | In distribution |
| 2257-340-11 | 11 mm, Diameter | In distribution |
| 2257-320-01 | 11 mm, Diameter | In distribution |
| 2257-440-03 | 13 mm, Diameter | In distribution |
| 2257-65-65 | 6.5 mm Diameter | In distribution |
| 2257-360-13 | 13 mm, Diameter | In distribution |
| 2257-380-13 | 13 mm, Diameter | In distribution |
| 2257-480-02 | Length 48 cm | In distribution |
| 2257-400-00 | Length 40 cm | In distribution |
| 2257-60-65 | Length 60 mm | In distribution |
| 2257-380-03 | Length 38 cm | In distribution |
| 2257-320-11 | 11 mm, Diameter | In distribution |
| 2259-01-30 | 11 mm Diameter | In distribution |
| 2257-500-02 | Length 50 cm | In distribution |
| 2259-01-52 | Length 120 mm | In distribution |
| 2259-09-05 | 5 mm Head Height | In distribution |
| 00-2258-052-13 | In distribution | |
| 2257-460-01 | 11 mm, Diameter | In distribution |
| 2257-480-14 | 14 mm, Diameter | In distribution |
| 2257-300-10 | Length 30 cm | In distribution |
| 2259-08-20 | 20 mm Head Height | In distribution |
| 2259-07-05 | 5 mm Head Height | In distribution |
| 2257-70-65 | 6.5 mm Diameter | In distribution |
| 2257-105-65 | 6.5 mm Diameter | In distribution |
| 2259-01-35 | 11 mm Diameter | In distribution |
| 2259-01-37 | Length 90 mm | In distribution |
| 2257-480-13 | Length 48 cm | In distribution |
| 00-2258-087-00 | In distribution | |
| 2257-360-04 | Length 36 cm | In distribution |
| 00-2258-052-05 | In distribution | |
| 2257-380-11 | 11 mm, Diameter | In distribution |
| 2257-400-03 | 13 mm, Diameter | In distribution |
| 2257-480-00 | Length 48 cm | In distribution |
| 2257-500-03 | Length 50 cm | In distribution |
| 2257-340-03 | 13 mm, Diameter | In distribution |
| 2257-75-65 | 6.5 mm Diameter | In distribution |
| 2257-480-10 | Length 48 cm | In distribution |
| 2257-340-04 | 14 mm, Diameter | In distribution |
| 2257-400-04 | Length 40 cm | In distribution |
| 2257-400-13 | 13 mm, Diameter | In distribution |
| 2256-02-52 | Length 120 mm | In distribution |
| 2257-340-01 | 11 mm, Diameter | In distribution |
| 2257-80-65 | 6.5 mm Diameter | In distribution |
| 2257-340-10 | Length 34 cm | In distribution |
| 2257-180-14 | 14 mm, Diameter | In distribution |
| 00-2258-087-02 | In distribution | |
| 2257-420-14 | Length 42 cm | In distribution |
| 00-2258-052-12 | In distribution | |
| 2256-02-42 | Length 100 mm | In distribution |
| 2259-01-32 | Length 80 mm | In distribution |
| 2257-460-02 | Length 46 cm | In distribution |
| 2257-480-12 | 12 mm, Diameter | In distribution |
| 2257-420-10 | 10 mm, Diameter | In distribution |
| 2257-460-10 | 10 mm, Diameter | In distribution |
| 2257-400-02 | 12 mm, Diameter | In distribution |
| 2253-90-45 | Length 90 mm | In distribution |
| 2258-53 | Withdrawn | |
| 2258-78 | Withdrawn |
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 |
| Natural Nail® | Zimmer, Inc. | 552 |
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
36 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 | 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 |
| 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. | 1499 | 2019-05-15 |
| 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. | 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. | 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, 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. | 50 | 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. | 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. | 268 | 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. | 1777 | 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. | 7 | 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. | 1622 | 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. | 58320 | 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. | 1394 | 2017-04-13 |
| 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 |
| 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 |
| 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 |
| Zimmer, Inc. | 510(k) number | 2009-06-05 | Not classified | Process control | Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa. | 120 of both products | 2009-12-22 |
| Zimmer, Inc. | 510(k) number | 2009-06-05 | Not classified | Process control | Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa. | 120 of both products | 2009-12-22 |
| Zimmer, Inc. | 510(k) number | 2004-03-16 | Not classified | Other | One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation. | 33 units | 2004-07-02 |
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 |
|---|---|---|---|---|---|
| 2025-12-02 | 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 | |
| 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 |
| 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 |
| 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 |
| 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 |
| 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19483 total products | 2020-11-18 |
| 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19483 total products | 2020-11-18 |
| 2018-03-26 | Class II | Under Investigation by firm | Potential failure of sterile packaging seal. | 19483 total products | 2020-11-18 |
| 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 |
| 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 |
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.