VerSys¿ Cemented Revision Calcar — Class II medical device recall Z-0277-2014
Terminated recall by Zimmer, Inc., reported 2013-11-20, distributed nationwide. Based on a review of historic packaging validations, it was determined that a subset of product packaged in on
| Recall number | Z-0277-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-08-28 |
| Classified | 2013-11-14 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2015-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BO, CA, CH, CL, DE, DZ, ES, FI, FR, GB, GR, GT, HN, HR, IL, IN, IT, JO, JP, KR, MA, MY, NI, PE, PT, RS, SA, SG, TR, VE, ZA |
| Quantity | 12,866 units |
| Reason classes | potency, sterility, packaging |
Product
VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
Reason for recall
Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing (seal integrity and seal strength) to provid
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-0277-2014. 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.