Affixus®
272 catalogue numbers from 815410320, 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
272catalogue 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) | K150867 |
| Record published | 2024-11-09 |
| Record revised | 2025-02-06 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 815410320 | Ø10 mm Length 320 mm | In distribution |
| 211304011 | In distribution | |
| 815809460 | Ø9 mm Length 460 mm Left | In distribution |
| 814965130 | Ø6.5 mm Length 130 mm | In distribution |
| 815613420 | Ø13 mm Length 420 mm Left | In distribution |
| 815811420 | Ø11 mm Length 420 mm Left | In distribution |
| 815512480 | Ø12 mm Length 480 mm Right | In distribution |
| 815511340 | Ø11 mm Length 340 mm Right | In distribution |
| 815511280 | Ø11 mm Length 280 mm Right | In distribution |
| 815410290 | Ø10 mm Length 290 mm | In distribution |
| 815614380 | Ø14 mm Length 380 mm Left | In distribution |
| 814650022 | Ø5 mm Length 22 mm | In distribution |
| 211304014 | In distribution | |
| 814707110 | Ø14 mm Length 10 mm | In distribution |
| 211304081 | In distribution | |
| 815409300 | Ø9 mm Length 300 mm | In distribution |
| 815709440 | Ø9 mm Length 440 mm Right | In distribution |
| 814965100 | Ø6.5 mm Length 100 mm | In distribution |
| 815810320 | Ø10 mm Length 320 mm Left | In distribution |
| 815509420 | Ø9 mm Length 420 mm Right | In distribution |
| 815514480 | Ø14 mm Length 480 mm Right | In distribution |
| 814540090 | Ø4 mm Length 90 mm | In distribution |
| 211304013 | In distribution | |
| 815710280 | Ø10 mm Length 280 mm Right | In distribution |
| 814965085 | Ø6.5 mm Length 85 mm | In distribution |
| 814965090 | Ø6.5 mm Length 90 mm | In distribution |
| 815813440 | Ø13 mm Length 440 mm Left | In distribution |
| 815513320 | Ø13 mm Length 320 mm Right | In distribution |
| 815110380 | Ø10 mm Length 380 mm | In distribution |
| 815065120 | Ø6.5 mm Length 120 mm | In distribution |
| 815711380 | Ø11 mm Length 380 mm Right | In distribution |
| 815810380 | Ø10 mm Length 380 mm Left | In distribution |
| 815510400 | Ø10 mm Length 400 mm Right | In distribution |
| 815610280 | Ø10 mm Length 280 mm Left | In distribution |
| 815110420 | Ø10 mm Length 420 mm | In distribution |
| 814965125 | Ø6.5 mm Length 125 mm | In distribution |
| 815714460 | Ø14 mm Length 460 mm Right | In distribution |
| 815112420 | Ø12 mm Length 420 mm | In distribution |
| 815609480 | Ø9 mm Length 480 mm Left | In distribution |
| 815411410 | Ø11 mm Length 410 mm | In distribution |
| 815410340 | Ø10 mm Length 340 mm | In distribution |
| 814650135 | Ø5 mm Length 135 mm | In distribution |
| 815509380 | Ø9 mm Length 380 mm Right | In distribution |
| 815709460 | Ø9 mm Length 460 mm Right | In distribution |
| 815611440 | Ø11 mm Length 440 mm Left | In distribution |
| 814650020 | Ø5 mm Length 20 mm | In distribution |
| 815514440 | Ø14 mm Length 440 mm Right | In distribution |
| 815512260 | Ø12 mm Length 260 mm Right | In distribution |
| 815615420 | Ø15 mm Length 420 mm Left | In distribution |
| 814650075 | Ø5 mm Length 75 mm | In distribution |
| 815713260 | Ø13 mm Length 260 mm Right | In distribution |
| 814865125 | Ø6.5 mm Length 125 mm | In distribution |
| 815511380 | Ø11 mm Length 380 mm Right | In distribution |
| 815413400 | Ø13 mm Length 400 mm | In distribution |
| 814540054 | Ø4 mm Length 54 mm | In distribution |
| 815410400 | Ø10 mm Length 400 mm | In distribution |
| 815710360 | Ø10 mm Length 360 mm Right | In distribution |
| 815613460 | Ø13 mm Length 460 mm Left | In distribution |
| 815711360 | Ø11 mm Length 360 mm Right | In distribution |
| 815511320 | Ø11 mm Length 320 mm Right | In distribution |
| 815813320 | Ø13 mm Length 320 mm Left | In distribution |
| 815610440 | Ø10 mm Length 440 mm Left | In distribution |
| 815409250 | Ø9 mm Length 250 mm | In distribution |
| 814650085 | Ø5 mm Length 85 mm | In distribution |
| 815110320 | Ø10 mm Length 320 mm | In distribution |
| 815413240 | Ø13 mm Length 240 mm | In distribution |
| 814965110 | Ø6.5 mm Length 110 mm | In distribution |
| 211304023 | In distribution | |
| 815408380 | Ø8 mm Length 380 mm | In distribution |
| 815611480 | Ø11 mm Length 480 mm Left | In distribution |
| 815710400 | Ø10 mm Length 400 mm Right | In distribution |
| 815613320 | Ø13 mm Length 320 mm Left | In distribution |
| 815709340 | Ø9 mm Length 340 mm Right | In distribution |
| 815613340 | Ø13 mm Length 340 mm Left | In distribution |
| 815112380 | Ø12 mm Length 380 mm | In distribution |
| 815408330 | Ø8 mm Length 330 mm | In distribution |
| 815065110 | Ø6.5 mm Length 110 mm | In distribution |
| 815512360 | Ø12 mm Length 360 mm Right | In distribution |
| 815712420 | Ø12 mm Length 420 mm Right | In distribution |
| 815611340 | Ø11 mm Length 340 mm Left | In distribution |
| 815712340 | Ø12 mm Length 340 mm Right | In distribution |
| 815811320 | Ø11 mm Length 320 mm Left | In distribution |
| 814650038 | Ø5 mm Length 38 mm | In distribution |
| 814650070 | Ø5 mm Length 70 mm | In distribution |
| 211304021 | In distribution | |
| 814865095 | Ø6.5 mm Length 95 mm | In distribution |
| 815614360 | Ø14 mm Length 360 mm Left | In distribution |
| 815111360 | Ø11 mm Length 360 mm | In distribution |
| 815712320 | Ø12 mm Length 320 mm Right | In distribution |
| 815512460 | Ø12 mm Length 460 mm Right | In distribution |
| 814540046 | Ø4 mm Length 46 mm | In distribution |
| 815714340 | Ø14 mm Length 340 mm Right | In distribution |
| 815713460 | Ø13 mm Length 460 mm Right | In distribution |
| 815510320 | Ø10 mm Length 320 mm Right | In distribution |
| 815409290 | Ø9 mm Length 290 mm | In distribution |
| 814707055 | Ø13 mm Length 5 mm | In distribution |
| 814650024 | Ø5 mm Length 24 mm | In distribution |
| 815809340 | Ø9 mm Length 340 mm Left | In distribution |
| 815813360 | Ø13 mm Length 360 mm Left | In distribution |
| 814865100 | Ø6.5 mm Length 100 mm | In distribution |
| 815610400 | Ø10 mm Length 400 mm Left | In distribution |
| 815814300 | Ø14 mm Length 300 mm Left | In distribution |
| 815809400 | Ø9 mm Length 400 mm Left | In distribution |
| 815408310 | Ø8 mm Length 310 mm | In distribution |
| 815511260 | Ø11 mm Length 260 mm Right | In distribution |
| 211304019 | In distribution | |
| 814650036 | Ø5 mm Length 36 mm | In distribution |
| 815512400 | Ø12 mm Length 400 mm Right | In distribution |
| 815413270 | Ø13 mm Length 270 mm | In distribution |
| 815714280 | Ø14 mm Length 280 mm Right | In distribution |
| 815514340 | Ø14 mm Length 340 mm Right | In distribution |
| 815714320 | Ø14 mm Length 320 mm Right | In distribution |
| 814540048 | Ø4 mm Length 48 mm | In distribution |
| 815810440 | Ø10 mm Length 440 mm Left | In distribution |
| 815713360 | Ø13 mm Length 360 mm Right | In distribution |
| 815112320 | Ø12 mm Length 320 mm | In distribution |
| 815413410 | Ø13 mm Length 410 mm | In distribution |
| 814965080 | Ø6.5 mm Length 80 mm | In distribution |
| 211304015 | In distribution | |
| 815612460 | Ø12 mm Length 460 mm Left | In distribution |
| 814650048 | Ø5 mm Length 48 mm | In distribution |
| 814965105 | Ø6.5 mm Length 105 mm | In distribution |
| 814650044 | Ø5 mm Length 44 mm | In distribution |
| 815410270 | Ø10 mm Length 270 mm | In distribution |
| 815110400 | Ø10 mm Length 400 mm | In distribution |
| 815612360 | Ø12 mm Length 360 mm Left | In distribution |
| 814650105 | Ø5 mm Length 105 mm | In distribution |
| 815412410 | Ø12 mm Length 410 mm | In distribution |
| 815814460 | Ø14 mm Length 460 mm Left | In distribution |
| 814650050 | Ø5 mm Length 50 mm | In distribution |
| 815512300 | Ø12 mm Length 300 mm Right | In distribution |
| 815112360 | Ø12 mm Length 360 mm | In distribution |
| 815413330 | Ø13 mm Length 330 mm | In distribution |
| 814540080 | Ø4 mm Length 80 mm | In distribution |
| 814650095 | Ø5 mm Length 95 mm | In distribution |
| 814650115 | Ø5 mm Length 115 mm | In distribution |
| 815714380 | Ø14 mm Length 380 mm Right | In distribution |
| 814965065 | Ø6.5 mm Length 65 mm | In distribution |
| 815509320 | Ø9 mm Length 320 mm Right | In distribution |
| 815714440 | Ø14 mm Length 440 mm Right | In distribution |
| 815408350 | Ø8 mm Length 350 mm | In distribution |
| 815612300 | Ø12 mm Length 300 mm Left | In distribution |
| 815065100 | Ø6.5 mm Length 100 mm | In distribution |
| 815611380 | Ø11 mm Length 380 mm Left | In distribution |
| 211304020 | In distribution | |
| 815612320 | Ø12 mm Length 320 mm Left | In distribution |
| 815811460 | Ø11 mm Length 460 mm Left | In distribution |
| 815609400 | Ø9 mm Length 400 mm Left | In distribution |
| 814650052 | Ø5 mm Length 52 mm | In distribution |
| 815812280 | Ø12 mm Length 280 mm Left | In distribution |
| 814540020 | Ø4 mm Length 20 mm | In distribution |
| 815512320 | Ø12 mm Length 320 mm Right | In distribution |
| 815409400 | Ø9 mm Length 400 mm | In distribution |
| 211304080 | In distribution | |
| 815411240 | Ø11 mm Length 240 mm | In distribution |
| 815509280 | Ø9 mm Length 280 mm Right | In distribution |
| 815511480 | Ø11 mm Length 480 mm Right | In distribution |
| 815612260 | Ø12 mm Length 260 mm Left | In distribution |
| 815715340 | Ø15 mm Length 340 mm Right | In distribution |
| 815812420 | Ø12 mm Length 420 mm Left | In distribution |
| 815413390 | Ø13 mm Length 390 mm | In distribution |
| 815610300 | Ø10 mm Length 300 mm Left | In distribution |
| 815111340 | Ø11 mm Length 340 mm | In distribution |
| 815812380 | Ø12 mm Length 380 mm Left | In distribution |
| 814540028 | Ø4 mm Length 28 mm | In distribution |
| 815409350 | Ø9 mm Length 350 mm | In distribution |
| 814865075 | Ø6.5 mm Length 75 mm | In distribution |
| 815814440 | Ø14 mm Length 440 mm Left | In distribution |
| 815112400 | Ø12 mm Length 400 mm | In distribution |
| 814965060 | Ø6.5 mm Length 60 mm | In distribution |
| 211304082 | In distribution | |
| 815814380 | Ø14 mm Length 380 mm Left | In distribution |
| 815714360 | Ø14 mm Length 360 mm Right | In distribution |
| 211304083 | In distribution | |
| 815710300 | Ø10 mm Length 300 mm Right | In distribution |
| 815810420 | Ø10 mm Length 420 mm Left | In distribution |
| 815111400 | Ø11 mm Length 400 mm | In distribution |
| 815110300 | Ø10 mm Length 300 mm | In distribution |
| 815610260 | Ø10 mm Length 260 mm Left | In distribution |
| 815111300 | Ø11 mm Length 300 mm | In distribution |
| 815714400 | Ø14 mm Length 400 mm Right | In distribution |
| 815613360 | Ø13 mm Length 360 mm Left | In distribution |
| 815711420 | Ø11 mm Length 420 mm Right | In distribution |
| 815408370 | Ø8 mm Length 370 mm | In distribution |
| 815411280 | Ø11 mm Length 280 mm | In distribution |
| 815410380 | Ø10 mm Length 380 mm | In distribution |
| 815612440 | Ø12 mm Length 440 mm Left | In distribution |
| 815811440 | Ø11 mm Length 440 mm Left | In distribution |
| 815111420 | Ø11 mm Length 420 mm | In distribution |
| 815814320 | Ø14 mm Length 320 mm Left | In distribution |
| 814707115 | Ø14 mm Length 15 mm | In distribution |
| 815065045 | Ø6.5 mm Length 45 mm | In distribution |
| 815515420 | Ø15 mm Length 420 mm Right | In distribution |
| 211304012 | In distribution | |
| 815710260 | Ø10 mm Length 260 mm Right | In distribution |
| 815809260 | Ø9 mm Length 260 mm Left | In distribution |
| 815614280 | Ø14 mm Length 280 mm Left | In distribution |
| 814540026 | Ø4 mm Length 26 mm | In distribution |
| 814540065 | Ø4 mm Length 65 mm | In distribution |
| 815410390 | Ø10 mm Length 390 mm | In distribution |
| 815613280 | Ø13 mm Length 280 mm Left | In distribution |
| 814650065 | Ø5 mm Length 65 mm | In distribution |
| 815709420 | Ø9 mm Length 420 mm Right | In distribution |
| 814650060 | Ø5 mm Length 60 mm | In distribution |
| 815111380 | Ø11 mm Length 380 mm | In distribution |
| 814540030 | Ø4 mm Length 30 mm | In distribution |
| 815408390 | Ø8 mm Length 390 mm | In distribution |
| 815112300 | Ø12 mm Length 300 mm | In distribution |
| 815515340 | Ø15 mm Length 340 mm Right | In distribution |
| 815510420 | Ø10 mm Length 420 mm Right | In distribution |
| 815408250 | Ø8 mm Length 250 mm | In distribution |
| 815614440 | Ø14 mm Length 440 mm Left | In distribution |
| 814650100 | Ø5 mm Length 100 mm | In distribution |
| 814650032 | Ø5 mm Length 32 mm | In distribution |
| 815510260 | Ø10 mm Length 260 mm Right | In distribution |
| 814707060 | Ø13 mm Length 10 mm | In distribution |
| 815814340 | Ø14 mm Length 340 mm Left | In distribution |
| 815811400 | Ø11 mm Length 400 mm Left | In distribution |
| 211304032 | In distribution | |
| 815711260 | Ø11 mm Length 260 mm Right | In distribution |
| 815510300 | Ø10 mm Length 300 mm Right | In distribution |
| 814650030 | Ø5 mm Length 30 mm | In distribution |
| 815610320 | Ø10 mm Length 320 mm Left | In distribution |
| 815409380 | Ø9 mm Length 380 mm | In distribution |
| 815513300 | Ø13 mm Length 300 mm Right | In distribution |
| 815713300 | Ø13 mm Length 300 mm Right | In distribution |
| 815614320 | Ø14 mm Length 320 mm Left | In distribution |
| 815412270 | Ø12 mm Length 270 mm | In distribution |
| 815614480 | Ø14 mm Length 480 mm Left | In distribution |
| 815511460 | Ø11 mm Length 460 mm Right | In distribution |
| 815710420 | Ø10 mm Length 420 mm Right | In distribution |
| 815514360 | Ø14 mm Length 360 mm Right | In distribution |
| 815609280 | Ø9 mm Length 280 mm Left | In distribution |
| 815609380 | Ø9 mm Length 380 mm Left | In distribution |
| 815809320 | Ø9 mm Length 320 mm Left | In distribution |
| 211304022 | In distribution | |
| 814540034 | Ø4 mm Length 34 mm | In distribution |
| 815510340 | Ø10 mm Length 340 mm Right | In distribution |
| 815611300 | Ø11 mm Length 300 mm Left | In distribution |
| 815613300 | Ø13 mm Length 300 mm Left | In distribution |
| 815610480 | Ø10 mm Length 480 mm Left | In distribution |
| 815112340 | Ø12 mm Length 340 mm | In distribution |
| 815814280 | Ø14 mm Length 280 mm Left | In distribution |
| 815809280 | Ø9 mm Length 280 mm Left | In distribution |
| 815110360 | Ø10 mm Length 360 mm | In distribution |
| 814707065 | Ø13 mm Length 15 mm | In distribution |
| 815409280 | Ø9 mm Length 280 mm | In distribution |
| 815709280 | Ø9 mm Length 280 mm Right | In distribution |
| 815514460 | Ø14 mm Length 460 mm Right | In distribution |
| 815410410 | Ø10 mm Length 410 mm | In distribution |
Showing 250 of 272 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 |
| 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
17 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 |
|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
Recalls
23 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 |
|---|---|---|---|---|---|
| 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. | 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.