FDA Device recall Z-1014-2014
ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900 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-1014-2014 |
| 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
ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
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 | 60068459 60152928 60198635 60254679 60393366 60550119 60604063 60630562 60654332 60688667 60705395 60804579…60068459 60152928 60198635 60254679 60393366 60550119 60604063 60630562 60654332 60688667 60705395 60804579 61238538 60137582 60155302 60198636 60338337 60435949 60550120 60604064 60630563 60664392 60705397 61034009 60154177 60155303 60172595 60203125 60208505 60293052 60293053 60385452 60435952 60451975 60513716 60550121 60569137 60621316 60653000 60671936 60690725 60700503 60783464 60820534 60860511 60860513 60860514 60922581 60931393 61057541 61057542 61091712 61144231 61144232 61175725 61179682 61213680 61213685 61226623 61458924 61496585 61496586 61516718 61652312 61987298 60931393R 60068461 60085970 60112862 60137583 60167084 60177165 60203127 60208506 60230633 60254680 60263992 60281385 60293054 60323227 60323228 60338339 60351950 60363732 60381044 60381045 60429147 60451979 60472802 60488988 60513720 60536838 60544315 60550122 60550123 60569139 60585209 60604065 60604067 60646729 |
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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-1014-2014%22
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