FDA Device recall Z-2314-2020
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for tempora…
- FDA Device
- Class II
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for tempora… by Biomet, citing distributed to the field without having completed design history files or design transfer activities.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2314-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-14 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomet |
| Distribution | US |
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Reason
Distributed to the field without having completed design history files or design transfer activities
Identifiers
| code_info | Lot Number: 452448 (01)00887868151354(10)452448 462794 (01)00887868151354(10)462794 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2314-2020%22
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