FDA Device recall Z-0882-2021
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteot…
- FDA Device
- Class II
- terminated
- Published 2021-01-27
On 2021-01-27 the FDA classified a Class II recall of A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteot… by Biomet, citing the instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0882-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-23 |
| Published | 2021-01-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomet |
| Distribution | US |
Product
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.
Reason
The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
Identifiers
| code_info | Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167 |
|---|
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-0882-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.