FDA Device recall Z-1039-2014
COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN) 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-1039-2014 |
| 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
COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
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 | 60102586 60132471 60142537 60145090 60208438 60210902 60218747 60265332 60316667 60380272 60387522 60425078…60102586 60132471 60142537 60145090 60208438 60210902 60218747 60265332 60316667 60380272 60387522 60425078 60451935 60491775 60504962 60538423 60569271 60629869 60629870 60671868 60690620 60735901 60790633 60828403 60859841 60885052 60910023 60926381 60938165 60997341 61008512 61045578 61049489 61063879 61085581 61087377 61120002 61160484 61160485 61179531 61276833 61441956 61457387 61513903 61626104 61660625 61664773 61677697 61677702 61705589 61707801 61729145 61729146 61729745 61750828 62109253 60049193 60096554 60101711 60102587 60102588 60123238 60130244 60139604 60140249 60140250 60141583 60142539 60145093 60165156 60165157 60169713 60169714 60175619 60177171 60193845 60195824 60195825 60218748 60222629 60222631 60231265 60231266 60240376 60249923 60249924 60257490 60257491 60265333 60275014 60275015 60297515 60307915 60307916 60316668 60316669 60322678 60330555 60332252 60338176 |
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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-1039-2014%22
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