FDA Device recall Z-1131-2021
Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixati…
- FDA Device
- Class II
- terminated
- Published 2021-02-24
On 2021-02-24 the FDA classified a Class II recall of Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixati… by Biomet, citing zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint inv….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1131-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-15 |
| Published | 2021-02-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomet |
| Distribution | US |
Product
Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Reason
Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
Identifiers
| code_info | Model No.: 115395, Lot No.: 077170, UDI: (01) 00880304677074 (17) 301010 (10) 077170 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1131-2021%22
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