FDA Device recall Z-1021-2014
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST 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-1021-2014 |
| 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
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
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 | 61069810 61239668 60817848 60859538 61069808 60564425 60629462 61098322 60586662 60119138 60125003 60138865…61069810 61239668 60817848 60859538 61069808 60564425 60629462 61098322 60586662 60119138 60125003 60138865 60138866 60144492 60144493 60160818 60160819 60160820 60177055 60177056 60190191 60190192 60194090 60194091 60210614 60210615 60210616 60244036 60244045 60254555 60254559 60262556 60266099 60280552 60294695 60310003 60310009 60310017 60337897 60350850 60359183 60367447 60382117 60403684 60403685 60420502 60441357 60461431 60475823 60494867 60507637 60507638 60535476 60541148 60579568 60627444 60652013 60656130 60671226 60681755 60713063 60721666 60746532 60769330 60786197 60805886 60875806 60884324 60897175 60931950 60965132 60990158 61002035 61035915 61070777 61077276 61137977 61197943 61227779 61249364 61249365 61287995 61319958 61357847 61422276 61454665 61458496 61504823 61548591 61593075 61770510 61895892 62016765 62079773 62090497 60097574 60097576 60097579 60097580 60125006 |
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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-1021-2014%22
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