Data Foundry

Medical device recalls 2020

A — Class II medical device recall Z-2305-2020

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 numberZ-2305-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBiomet, Miami, FL, United States
Recall initiated2020-05-14
Classified2020-06-09
Reported by FDA2020-06-17
Terminated2021-04-08
DistributedNationwide (US)
Countries outside the USAU, CA, CL, CN, JP, MY, NL
Quantity5 ous
UPC / GTIN / UDI-DI00887868135026
Lot numbersP0217
Model numbers110017551

Product

A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - 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-2305-2020. 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.