Anatomical Shoulder" Revision Humeral stem — Class II medical device recall Z-0227-2013
Terminated recall by Zimmer, Inc., reported 2012-11-14, distributed nationwide. Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by th
| Recall number | Z-0227-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-09-04 |
| Classified | 2012-11-06 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2014-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 45 usa |
| Reason classes | labeling |
| Lot numbers | 2341901, 2347028, 2348099, 2380422, 2398402, 2398475, 2435527, 2485014 |
| Model numbers | 01.04215.072, 01.04215.092, 01.04215.122, 01.04215.142, 01.04217.072, 01.04217.132 |
Product
Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
Reason for recall
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
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-0227-2013. 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.