FDA Device recall Z-1031-2014
12/14 COCR FEMORAL HEAD (2, 3 and 4)
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of 12/14 COCR FEMORAL HEAD (2, 3 and 4) by Zimmer, citing 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 deter….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1031-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-11 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
Reason
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 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
Identifiers
| code_info | 365365 365664 60095144 60106294 60106295 60106296 60109696 60109697 60124944 60124945 60134520 60134521 601…365365 365664 60095144 60106294 60106295 60106296 60109696 60109697 60124944 60124945 60134520 60134521 60138381 60138382 60157045 60157046 60157047 60173107 60173557 60178493 60189233 60190544 60196799 60205060 60205062 60215717 60232508 60232571 60236680 60238555 60239170 60239172 60239173 60249946 60250022 60250024 60262696 60262703 60274914 60274915 60274916 60275490 60275491 60275492 60346324 60346325 60349076 60349077 60349078 60349079 60349080 60389118 60392706 60425077 60431157 60431160 60431161 60458471 60466704 60475849 60484210 60499766 60508292 60517078 60524278 60535550 60535551 60541380 60541381 60568674 60579071 60587849 60597445 60597446 60610372 60610373 60623786 60627203 60656086 60664595 60670142 60677138 60687291 60687418 60687419 60718653 60722394 60732757 60746715 60758427 60758430 60769368 60780501 60796169 60806142 60816001 60821870 60823970 60838548 60847561 6085 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1031-2014%22
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