Data Foundry

Medical device recalls 2012

OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8 — Class II medical device recall Z-0471-2013

Terminated recall by Biomet, Inc., reported 2012-12-12, distributed nationwide. Biomet has initiated this action following an investigation which identified that the thin shaft reamer may ge

Recall numberZ-0471-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBiomet, Inc., Warsaw, IN, United States
Recall initiated2012-11-01
Classified2012-12-04
Reported by FDA2012-12-12
Terminated2013-04-29
DistributedNationwide (US)
Countries outside the USJP, NL
Quantity46
Lot numbers013020, 050310, 056280, 154670, 418380, 691220, 755510, 860171, 866460
Model numbers132-472661, 32-472661, 8.0

Product

OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.

Reason for recall

Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.

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-0471-2013. 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.