Affixus®
267 catalogue numbers from 815614400, listed by Zimmer, Inc., United States, under Screw, Fixation, Bone. 31 manufacturers in China are registered for this product code.
31manufacturers in China registered for this device type
267catalogue numbers in this listing
12510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K241651 |
| Record published | 2024-10-16 |
| Record revised | 2025-02-06 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 |
|---|---|---|
| 815614400 | Ø14 mm Length 400 mm Left | In distribution |
| 815615340 | Ø15 mm Length 340 mm Left | In distribution |
| 814540036 | Ø4 mm Length 36 mm | In distribution |
| 815409240 | Ø9 mm Length 240 mm | In distribution |
| 815514420 | Ø14 mm Length 420 mm Right | In distribution |
| 814650042 | Ø5 mm Length 42 mm | In distribution |
| 815612400 | Ø12 mm Length 400 mm Left | In distribution |
| 815513420 | Ø13 mm Length 420 mm Right | In distribution |
| 814865105 | Ø6.5 mm Length 105 mm | In distribution |
| 815712380 | Ø12 mm Length 380 mm Right | In distribution |
| 815412420 | Ø12 mm Length 420 mm | In distribution |
| 814965095 | Ø6.5 mm Length 95 mm | In distribution |
| 815411340 | Ø11 mm Length 340 mm | In distribution |
| 814865115 | Ø6.5 mm Length 115 mm | In distribution |
| 815408300 | Ø8 mm Length 300 mm | In distribution |
| 815811380 | Ø11 mm Length 380 mm Left | In distribution |
| 815515460 | Ø15 mm Length 460 mm Right | In distribution |
| 815609300 | Ø9 mm Length 300 mm Left | In distribution |
| 815609440 | Ø9 mm Length 440 mm Left | In distribution |
| 815712360 | Ø12 mm Length 360 mm Right | In distribution |
| 815065115 | Ø6.5 mm Length 115 mm | In distribution |
| 814540024 | Ø4 mm Length 24 mm | In distribution |
| 815709360 | Ø9 mm Length 360 mm Right | In distribution |
| 815712280 | Ø12 mm Length 280 mm Right | In distribution |
| 815413290 | Ø13 mm Length 290 mm | In distribution |
| 814706000 | In distribution | |
| 814707005 | Ø11 mm Length 5 mm | In distribution |
| 815612420 | Ø12 mm Length 420 mm Left | In distribution |
| 815510280 | Ø10 mm Length 280 mm Right | In distribution |
| 815815380 | Ø15 mm Length 380 mm Left | In distribution |
| 815513380 | Ø13 mm Length 380 mm Right | In distribution |
| 815711340 | Ø11 mm Length 340 mm Right | In distribution |
| 815813280 | Ø13 mm Length 280 mm Left | In distribution |
| 814965070 | Ø6.5 mm Length 70 mm | In distribution |
| 815810360 | Ø10 mm Length 360 mm Left | In distribution |
| 815812320 | Ø12 mm Length 320 mm Left | In distribution |
| 814540032 | Ø4 mm Length 32 mm | In distribution |
| 815410310 | Ø10 mm Length 310 mm | In distribution |
| 815408270 | Ø8 mm Length 270 mm | In distribution |
| 815408260 | Ø8 mm Length 260 mm | In distribution |
| 815712400 | Ø12 mm Length 400 mm Right | In distribution |
| 815512440 | Ø12 mm Length 440 mm Right | In distribution |
| 815710340 | Ø10 mm Length 340 mm Right | In distribution |
| 815713340 | Ø13 mm Length 340 mm Right | In distribution |
| 815065105 | Ø6.5 mm Length 105 mm | In distribution |
| 815411380 | Ø11 mm Length 380 mm | In distribution |
| 815514320 | Ø14 mm Length 320 mm Right | In distribution |
| 814650056 | Ø5 mm Length 56 mm | In distribution |
| 815411390 | Ø11 mm Length 390 mm | In distribution |
| 815712300 | Ø12 mm Length 300 mm Right | In distribution |
| 814650026 | Ø5 mm Length 26 mm | In distribution |
| 814540022 | Ø4 mm Length 22 mm | In distribution |
| 815811340 | Ø11 mm Length 340 mm Left | In distribution |
| 814540075 | Ø4 mm Length 75 mm | In distribution |
| 815413280 | Ø13 mm Length 280 mm | In distribution |
| 815408320 | Ø8 mm Length 320 mm | In distribution |
| 815715420 | Ø15 mm Length 420 mm Right | In distribution |
| 815815460 | Ø15 mm Length 460 mm Left | In distribution |
| 815065125 | Ø6.5 mm Length 125 mm | In distribution |
| 815514300 | Ø14 mm Length 300 mm Right | In distribution |
| 815511400 | Ø11 mm Length 400 mm Right | In distribution |
| 815610360 | Ø10 mm Length 360 mm Left | In distribution |
| 815812440 | Ø12 mm Length 440 mm Left | In distribution |
| 815412330 | Ø12 mm Length 330 mm | In distribution |
| 815610420 | Ø10 mm Length 420 mm Left | In distribution |
| 814865060 | Ø6.5 mm Length 60 mm | In distribution |
| 815715460 | Ø15 mm Length 460 mm Right | In distribution |
| 814865070 | Ø6.5 mm Length 70 mm | In distribution |
| 815712260 | Ø12 mm Length 260 mm Right | In distribution |
| 815711460 | Ø11 mm Length 460 mm Right | In distribution |
| 814965135 | Ø6.5 mm Length 135 mm | In distribution |
| 815510380 | Ø10 mm Length 380 mm Right | In distribution |
| 815411370 | Ø11 mm Length 370 mm | In distribution |
| 814540038 | Ø4 mm Length 38 mm | In distribution |
| 815411270 | Ø11 mm Length 270 mm | In distribution |
| 815613440 | Ø13 mm Length 440 mm Left | In distribution |
| 815412350 | Ø12 mm Length 350 mm | In distribution |
| 815509340 | Ø9 mm Length 340 mm Right | In distribution |
| 815613480 | Ø13 mm Length 480 mm Left | In distribution |
| 815065080 | Ø6.5 mm Length 80 mm | In distribution |
| 815411330 | Ø11 mm Length 330 mm | In distribution |
| 815713440 | Ø13 mm Length 440 mm Right | In distribution |
| 815065055 | Ø6.5 mm Length 55 mm | In distribution |
| 815511440 | Ø11 mm Length 440 mm Right | In distribution |
| 815411310 | Ø11 mm Length 310 mm | In distribution |
| 815710320 | Ø10 mm Length 320 mm Right | In distribution |
| 815411320 | Ø11 mm Length 320 mm | In distribution |
| 815812360 | Ø12 mm Length 360 mm Left | In distribution |
| 815813380 | Ø13 mm Length 380 mm Left | In distribution |
| 815810400 | Ø10 mm Length 400 mm Left | In distribution |
| 815610340 | Ø10 mm Length 340 mm Left | In distribution |
| 815510460 | Ø10 mm Length 460 mm Right | In distribution |
| 815408340 | Ø8 mm Length 340 mm | In distribution |
| 815613400 | Ø13 mm Length 400 mm Left | In distribution |
| 815611360 | Ø11 mm Length 360 mm Left | In distribution |
| 814650040 | Ø5 mm Length 40 mm | In distribution |
| 815811360 | Ø11 mm Length 360 mm Left | In distribution |
| 814865085 | Ø6.5 mm Length 85 mm | In distribution |
| 815611260 | Ø11 mm Length 260 mm Left | In distribution |
| 814540040 | Ø4 mm Length 40 mm | In distribution |
| 815514400 | Ø14 mm Length 400 mm Right | In distribution |
| 815812300 | Ø12 mm Length 300 mm Left | In distribution |
| 815710380 | Ø10 mm Length 380 mm Right | In distribution |
| 815065060 | Ø6.5 mm Length 60 mm | In distribution |
| 815614460 | Ø14 mm Length 460 mm Left | In distribution |
| 815809300 | Ø9 mm Length 300 mm Left | In distribution |
| 815813300 | Ø13 mm Length 300 mm Left | In distribution |
| 815513280 | Ø13 mm Length 280 mm Right | In distribution |
| 815614300 | Ø14 mm Length 300 mm Left | In distribution |
| 815410330 | Ø10 mm Length 330 mm | In distribution |
| 815409320 | Ø9 mm Length 320 mm | In distribution |
| 815709380 | Ø9 mm Length 380 mm Right | In distribution |
| 814865135 | Ø6.5 mm Length 135 mm | In distribution |
| 815713280 | Ø13 mm Length 280 mm Right | In distribution |
| 814540052 | Ø4 mm Length 52 mm | In distribution |
| 815408420 | Ø8 mm Length 420 mm | In distribution |
| 815713420 | Ø13 mm Length 420 mm Right | In distribution |
| 815512380 | Ø12 mm Length 380 mm Right | In distribution |
| 815810460 | Ø10 mm Length 460 mm Left | In distribution |
| 814965120 | Ø6.5 mm Length 120 mm | In distribution |
| 815813400 | Ø13 mm Length 400 mm Left | In distribution |
| 815513480 | Ø13 mm Length 480 mm Right | In distribution |
| 815714420 | Ø14 mm Length 420 mm Right | In distribution |
| 815409370 | Ø9 mm Length 370 mm | In distribution |
| 815412380 | Ø12 mm Length 380 mm | In distribution |
| 815610380 | Ø10 mm Length 380 mm Left | In distribution |
| 815711320 | Ø11 mm Length 320 mm Right | In distribution |
| 814650120 | Ø5 mm Length 120 mm | In distribution |
| 814540056 | Ø4 mm Length 56 mm | In distribution |
| 815813260 | Ø13 mm Length 260 mm Left | In distribution |
| 814540070 | Ø4 mm Length 70 mm | In distribution |
| 815512340 | Ø12 mm Length 340 mm Right | In distribution |
| 815510360 | Ø10 mm Length 360 mm Right | In distribution |
| 815809420 | Ø9 mm Length 420 mm Left | In distribution |
| 815611400 | Ø11 mm Length 400 mm Left | In distribution |
| 814865110 | Ø6.5 mm Length 110 mm | In distribution |
| 815810300 | Ø10 mm Length 300 mm Left | In distribution |
| 815611420 | Ø11 mm Length 420 mm Left | In distribution |
| 815514380 | Ø14 mm Length 380 mm Right | In distribution |
| 815811280 | Ø11 mm Length 280 mm Left | In distribution |
| 815413250 | Ø13 mm Length 250 mm | In distribution |
| 815511420 | Ø11 mm Length 420 mm Right | In distribution |
| 815614340 | Ø14 mm Length 340 mm Left | In distribution |
| 815714260 | Ø14 mm Length 260 mm Right | In distribution |
| 815509460 | Ø9 mm Length 460 mm Right | In distribution |
| 815815420 | Ø15 mm Length 420 mm Left | In distribution |
| 814540044 | Ø4 mm Length 44 mm | In distribution |
| 815810280 | Ø10 mm Length 280 mm Left | In distribution |
| 815709320 | Ø9 mm Length 320 mm Right | In distribution |
| 815814360 | Ø14 mm Length 360 mm Left | In distribution |
| 815065135 | Ø6.5 mm Length 135 mm | In distribution |
| 815615460 | Ø15 mm Length 460 mm Left | In distribution |
| 815713380 | Ø13 mm Length 380 mm Right | In distribution |
| 815065065 | Ø6.5 mm Length 65 mm | In distribution |
| 815810260 | Ø10 mm Length 260 mm Left | In distribution |
| 814865120 | Ø6.5 mm Length 120 mm | In distribution |
| 815609320 | Ø9 mm Length 320 mm Left | In distribution |
| 815714300 | Ø14 mm Length 300 mm Right | In distribution |
| 814707105 | Ø14 mm Length 5 mm | In distribution |
| 815410260 | Ø10 mm Length 260 mm | In distribution |
| 815813460 | Ø13 mm Length 460 mm Left | In distribution |
| 815512280 | Ø12 mm Length 280 mm Right | In distribution |
| 815610460 | Ø10 mm Length 460 mm Left | In distribution |
| 814540042 | Ø4 mm Length 42 mm | In distribution |
| 815509260 | Ø9 mm Length 260 mm Right | In distribution |
| 815509440 | Ø9 mm Length 440 mm Right | In distribution |
| 815412310 | Ø12 mm Length 310 mm | In distribution |
| 815409270 | Ø9 mm Length 270 mm | In distribution |
| 815711280 | Ø11 mm Length 280 mm Right | In distribution |
| 815410300 | Ø10 mm Length 300 mm | In distribution |
| 814650054 | Ø5 mm Length 54 mm | In distribution |
| 815609340 | Ø9 mm Length 340 mm Left | In distribution |
| 815814400 | Ø14 mm Length 400 mm Left | In distribution |
| 815065075 | Ø6.5 mm Length 75 mm | In distribution |
| 814650080 | Ø5 mm Length 80 mm | In distribution |
| 815711440 | Ø11 mm Length 440 mm Right | In distribution |
| 814707010 | Ø11 mm Length 10 mm | In distribution |
| 815412280 | Ø12 mm Length 280 mm | In distribution |
| 815412300 | Ø12 mm Length 300 mm | In distribution |
| 815809360 | Ø9 mm Length 360 mm Left | In distribution |
| 815509480 | Ø9 mm Length 480 mm Right | In distribution |
| 815815340 | Ø15 mm Length 340 mm Left | In distribution |
| 815812340 | Ø12 mm Length 340 mm Left | In distribution |
| 815614420 | Ø14 mm Length 420 mm Left | In distribution |
| 815408240 | Ø8 mm Length 240 mm | In distribution |
| 815611460 | Ø11 mm Length 460 mm Left | In distribution |
| 814650028 | Ø5 mm Length 28 mm | In distribution |
| 815408410 | Ø8 mm Length 410 mm | In distribution |
| 815513440 | Ø13 mm Length 440 mm Right | In distribution |
| 814650090 | Ø5 mm Length 90 mm | In distribution |
| 815409420 | Ø9 mm Length 420 mm | In distribution |
| 815510480 | Ø10 mm Length 480 mm Right | In distribution |
| 815812400 | Ø12 mm Length 400 mm Left | In distribution |
| 815514260 | Ø14 mm Length 260 mm Right | In distribution |
| 814650046 | Ø5 mm Length 46 mm | In distribution |
| 815711300 | Ø11 mm Length 300 mm Right | In distribution |
| 815065070 | Ø6.5 mm Length 70 mm | In distribution |
| 814865090 | Ø6.5 mm Length 90 mm | In distribution |
| 815513400 | Ø13 mm Length 400 mm Right | In distribution |
| 815611280 | Ø11 mm Length 280 mm Left | In distribution |
| 815709300 | Ø9 mm Length 300 mm Right | In distribution |
| 815509400 | Ø9 mm Length 400 mm Right | In distribution |
| 815065130 | Ø6.5 mm Length 130 mm | In distribution |
| 814865065 | Ø6.5 mm Length 65 mm | In distribution |
| 815412340 | Ø12 mm Length 340 mm | In distribution |
| 815614260 | Ø14 mm Length 260 mm Left | In distribution |
| 815611320 | Ø11 mm Length 320 mm Left | In distribution |
| 815811260 | Ø11 mm Length 260 mm Left | In distribution |
| 815413420 | Ø13 mm Length 420 mm | In distribution |
| 815515380 | Ø15 mm Length 380 mm Right | In distribution |
| 815615380 | Ø15 mm Length 380 mm Left | In distribution |
| 815613380 | Ø13 mm Length 380 mm Left | In distribution |
| 814540085 | Ø4 mm Length 85 mm | In distribution |
| 814650125 | Ø5 mm Length 125 mm | In distribution |
| 815514280 | Ø14 mm Length 280 mm Right | In distribution |
| 815814260 | Ø14 mm Length 260 mm Left | In distribution |
| 815513460 | Ø13 mm Length 460 mm Right | In distribution |
| 814650058 | Ø5 mm Length 58 mm | In distribution |
| 815612340 | Ø12 mm Length 340 mm Left | In distribution |
| 815809440 | Ø9 mm Length 440 mm Left | In distribution |
| 815410280 | Ø10 mm Length 280 mm | In distribution |
| 815813420 | Ø13 mm Length 420 mm Left | In distribution |
| 815710460 | Ø10 mm Length 460 mm Right | In distribution |
| 815811300 | Ø11 mm Length 300 mm Left | In distribution |
| 815612380 | Ø12 mm Length 380 mm Left | In distribution |
| 815812460 | Ø12 mm Length 460 mm Left | In distribution |
| 815711400 | Ø11 mm Length 400 mm Right | In distribution |
| 814965075 | Ø6.5 mm Length 75 mm | In distribution |
| 814865080 | Ø6.5 mm Length 80 mm | In distribution |
| 815513260 | Ø13 mm Length 260 mm Right | In distribution |
| 814707030 | Ø12 mm Length 5 mm | In distribution |
| 815065090 | Ø6.5 mm Length 90 mm | In distribution |
| 815412250 | Ø12 mm Length 250 mm | In distribution |
| 815509360 | Ø9 mm Length 360 mm Right | In distribution |
| 815712460 | Ø12 mm Length 460 mm Right | In distribution |
| 815411360 | Ø11 mm Length 360 mm | In distribution |
| 815510440 | Ø10 mm Length 440 mm Right | In distribution |
| 815412360 | Ø12 mm Length 360 mm | In distribution |
| 815609460 | Ø9 mm Length 460 mm Left | In distribution |
| 815814420 | Ø14 mm Length 420 mm Left | In distribution |
| 815809380 | Ø9 mm Length 380 mm Left | In distribution |
| 815709400 | Ø9 mm Length 400 mm Right | In distribution |
| 815511360 | Ø11 mm Length 360 mm Right | In distribution |
| 814865130 | Ø6.5 mm Length 130 mm | In distribution |
| 815410370 | Ø10 mm Length 370 mm | In distribution |
| 815413260 | Ø13 mm Length 260 mm | In distribution |
| 815513360 | Ø13 mm Length 360 mm Right | In distribution |
| 815065095 | Ø6.5 mm Length 95 mm | In distribution |
| 814650140 | Ø5 mm Length 140 mm | In distribution |
| 815609360 | Ø9 mm Length 360 mm Left | In distribution |
Showing 250 of 267 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152841 | 2015-11-24 |
| K143165 | 2015-03-31 |
| K142442 | 2014-10-03 |
| K130810 | 2013-09-19 |
| K112885 | 2011-12-19 |
| K111447 | 2011-10-05 |
| K101696 | 2010-09-10 |
| K070906 | 2007-05-01 |
| K060710 | 2006-04-26 |
| K051098 | 2005-07-07 |
| K946347 | 1995-07-11 |
| K792022 | 1979-10-26 |
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
40 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 |
|---|---|---|---|---|---|
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| 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 |
| 2015-12-09 | Class II | Labeling Change Control | Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside | 400 | 2016-11-08 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations faile | 972,125 units | 2015-09-15 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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.