Moore Hip Prosthesis Long Fenestrated Stem — Class II medical device recall Z-1981-2013
Terminated recall by Zimmer, Inc., reported 2013-08-28, distributed nationwide. Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was d
| Recall number | Z-1981-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-07-16 |
| Classified | 2013-08-17 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2015-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HK, MX, SA, SG |
| Quantity | 1,710 units |
| Reason classes | sterility |
Product
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
Reason for recall
Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a single packaging tray configuration, which
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-1981-2013. 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.