FDA Device recall Z-1038-2014
HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S 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-1038-2014 |
| 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
HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
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 | 60117014 60126278 60155287 60178897 60208414 60240381 60265317 60469641 60667003 60757014 60818325 60868434…60117014 60126278 60155287 60178897 60208414 60240381 60265317 60469641 60667003 60757014 60818325 60868434 60877876 60953936 61057493 61083223 61144260 61382948 61428496 61434453 60123231 60145083 60172484 60210898 60235186 60240382 60318917 60367391 60451947 60491785 60589767 60665682 60665683 60757015 60810891 60926378 60930484 60953937 60953938 61045584 61109124 61135014 61144262 61428498 61437196 60096548 60109535 60111962 60126279 60132072 60135124 60142531 60152397 60165150 60169711 60196507 60208415 60218735 60235187 60244038 60247673 60291570 60303879 60308478 60308479 60323219 60429155 60435646 60451952 60472779 60487172 60491786 60501138 60501139 60603149 60629958 60652968 60665904 60714756 60714757 60735916 60757016 60810892 60818328 60953942 61008526 61012463 61012464 61012465 61012466 61045586 61045587 61045588 61144264 61428502 61437198 61490670 61754462 60096549 60101706 |
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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-1038-2014%22
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