FDA Device recall Z-2311-2020
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal f…
- 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 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal f… 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-2311-2020 |
| 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 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - 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: J3853404 (01)00887868134500(17)260813(10)J3853404 |
|---|
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-2311-2020%22
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