FDA Device recall Z-1002-2014
HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520 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-1002-2014 |
| 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 MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.
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 | 60135114 60152390 60235174 60253671 60303868 60318915 60406045 60469637 60538425 60629952 60708626 60713650…60135114 60152390 60235174 60253671 60303868 60318915 60406045 60469637 60538425 60629952 60708626 60713650 60845570 60885012 61156076 61290771 60097888 60126180 60155283 60235175 60270647 60278995 60393280 60425089 60472771 60538426 60555772 60557775 60588046 60591903 60603145 60715075 60845571 60885014 61316528 61616158 61749182 60111959 60140238 60162141 60175614 60208384 60218727 60278996 60285802 60291544 60406046 60435612 60487168 60550156 60555773 60557774 60576766 60591904 60603146 60859714 60885015 61075639 61103192 61166254 61290772 61650519 61750812 60093352 60101703 60115126 60140239 60141562 60186799 60195341 60253673 60265299 60270648 60291547 60380281 60393281 60406047 60472772 60478980 60536890 60555774 60557776 60588047 60591905 60708627 60845573 60845574 60859715 61019223 61103193 61117518 61144243 61434451 61473776 61635184 61650520 61750818 60094821 60115127 60123222 |
|---|
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-1002-2014%22
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