FDA Device recall Z-1016-2014
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6 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-1016-2014 |
| 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
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.
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 | 60484301 60536380 60565715 60753818 60817438 60864746 61003323 61059514 61081364 61121949 61135827 61387138…60484301 60536380 60565715 60753818 60817438 60864746 61003323 61059514 61081364 61121949 61135827 61387138 61783644 365466 60096346 60097010 60259990 60422473 60459752 60515365 60674982 60715057 60768520 60787821 60799626 60799627 61012710 61029791 61029797 61075345 61103552 61103553 61121950 61121951 61135828 61883369 61901575 61938344 369678 369843 60242811 60260004 60317143 60370104 60411929 60411932 60441611 60501819 60501820 60501821 60540465 60553615 60715059 60759283 60759284 60759285 60787991 60799628 60979642 61003325 61012729 61059519 61121952 61121954 61222215 61339786 61398793 61528632 61541580 61565702 61589080 61613237 61921999 61938346 60085561 60096349 60097011 60124640 60134157 60148294 60154764 60154765 60169374 60169375 60187551 60187552 60242814 60260197 60274423 60301862 60313429 60335338 60395245 60395246 60422533 60442559 60484312 60501825 60511856 60553618 605744 |
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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-1016-2014%22
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