A — Class II medical device recall Z-2313-2020
Terminated recall by Biomet, reported 2020-06-17, distributed nationwide. Distributed to the field without having completed design history files or design transfer activities
| Recall number | Z-2313-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Miami, FL, United States |
| Recall initiated | 2020-05-14 |
| Classified | 2020-06-09 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2021-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, CN, JP, MY, NL |
| Quantity | 78 ous |
| UPC / GTIN / UDI-DI | 00887868151347 |
| Lot numbers | 429698 |
| Model numbers | 110025472 |
Product
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Reason for recall
Distributed to the field without having completed design history files or design transfer activities
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2313-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.