FDA Device recall Z-0388-2024
Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement by Biomet, citing anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0388-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-09 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomet |
| Distribution | US |
Product
Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570
Reason
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Identifiers
| code_info | Lot Numbers/UDI: 178570 (01)00880304461697(17)270811(10)535460; 535460R (01)00880304461697(17)270811(10)535460R; 6715…Lot Numbers/UDI: 178570 (01)00880304461697(17)270811(10)535460; 535460R (01)00880304461697(17)270811(10)535460R; 671550 (01)00880304461697(17)271124(10)671550 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0388-2024%22
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