HGP II ACETABULAR CUP MOD — Class II medical device recall Z-1026-2014
Terminated recall by Zimmer, Inc., reported 2014-02-26, distributed nationwide. Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMB
| Recall number | Z-1026-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-10-11 |
| Classified | 2014-02-20 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2017-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, IN, IT, JP, KR, NL, NO, NZ, PT, SE, SG, SK, TH, TR, TW |
| Quantity | 7,044,680 total |
| Reason classes | sterility, packaging |
Product
HGP II ACETABULAR CUP MOD
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1026-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.