Data Foundry

Medical device recalls 2020

Biomet Regenerex Primary Taper Cap Item Number 141269 — Class II medical device recall Z-0081-2021

Terminated recall by Biomet, Inc., reported 2020-10-14, distributed nationwide. Product not properly being aligned with the adequate gamma sterilization group and result in the product not b

Recall numberZ-0081-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBiomet, Inc., Warsaw, IN, United States
Recall initiated2020-09-04
Classified2020-10-08
Reported by FDA2020-10-14
Terminated2021-08-31
DistributedNationwide (US)
Countries outside the USCA, FI, GB, NL
Lot numbers015800, 023900, 058930, 200720, 313260, 324440, 324440R, 389060, 418430, 646040, 685300, 696280, 821980, 890320, 997610
Model numbers141269

Product

Biomet Regenerex Primary Taper Cap Item Number 141269

Reason for recall

Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

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-0081-2021. 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.