Superior Approach Resection Guide Assembly — Class II medical device recall Z-1548-2013
Terminated recall by Biomet, Inc., reported 2013-06-26, distributed nationwide. Biomet has initiated this action following an investigation which identified that the slot on the resection gu
| Recall number | Z-1548-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-05-15 |
| Classified | 2013-06-17 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2014-06-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, KR, NL |
| Quantity | 17 |
| Lot numbers | 318520, 644720 |
| Model numbers | 010001814 |
Product
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
Reason for recall
Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.
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-1548-2013. 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.