FDA Device recall Z-1025-2014
HGP II ACETABULAR CUP BON
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of HGP II ACETABULAR CUP BON 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-1025-2014 |
| 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
HGP II ACETABULAR CUP BON
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 | 60623443 61033908 60735135 60134455 61110848 60752636 60843726 61056222 60507678 60849459 60507690 60746629…60623443 61033908 60735135 60134455 61110848 60752636 60843726 61056222 60507678 60849459 60507690 60746629 60373606 60621446 60696755 60796167 60884344 60980958 61056223 61138012 61202414 61336976 61445414 61479406 61614837 61770499 61830570 62081013 62130755 62204493 60358198 60456662 60676065 60740508 60793418 60847420 60906711 60970346 61018601 61089082 61114463 61197927 61265392 61336977 61405285 61445415 61504347 61560488 61612779 61717244 61770502 61830571 61953544 62017892 62081014 62126660 62161132 62194338 62286121 60096604 60191638 60231058 60310154 60403566 60541147 60614769 60652079 60713588 60771842 60809040 60906712 60965173 61013603 61077260 61120020 61191847 61197928 61288037 61336979 61405286 61445416 61504866 61548952 61612780 61649225 61738511 61770503 61830572 61902195 61902196 62017893 62048834 62090584 62204494 62286108 60134456 60196503 60254570 60310198 60400186 |
|---|
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-1025-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.