FDA Device recall Z-1548-2013
Superior Approach Resection Guide Assembly
- FDA Device
- Class II
- terminated
- Published 2013-06-26
On 2013-06-26 the FDA classified a Class II recall of Superior Approach Resection Guide Assembly by Biomet, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1548-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-15 |
| Published | 2013-06-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | US |
Product
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
Reason
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.
Identifiers
| code_info | Catalog number: 010001814 and lot numbers: 318520 and 644720. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1548-2013%22
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