FDA Device recall Z-1032-2014
CPT 12/14 COCR (various sizes)
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of CPT 12/14 COCR (various sizes) 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-1032-2014 |
| 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
CPT 12/14 COCR (various sizes)
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 | 60225078 60261757 60274775 60310767 60398002 60491038 60638468 60638470 60685165 60776190 60797319 60927586…60225078 60261757 60274775 60310767 60398002 60491038 60638468 60638470 60685165 60776190 60797319 60927586 61189804 61237349 61342952 61468762 61490103 61596784 61748948 61764725 61840597 61917999 61964635 61999588 62003977 60261761 60261763 60776227 60776234 60846362 60916726 60952935 60979483 61162865 61189800 61356814 61460831 61523005 61739387 61748949 61829563 61996730 60310780 60335521 60412478 60457571 60533531 60776287 60776288 60823773 60990055 61045309 61351320 61500146 61727738 61727739 61957411 60217292 60245136 60330281 60448728 60491098 60648441 60704737 60748770 60776312 60797325 60916737 60952946 61261797 61293863 61307997 61733348 61758312 61868121 61881187 61885896 61991679 62001331 60245153 60245154 60323912 60372490 60589471 60704749 60723802 60748790 60921196 60957269 61045290 61061843 61104280 61114610 61733350 61987756 61991676 60217518 60310793 60330358 60589477 |
|---|
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-1032-2014%22
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