Z-0471-2013 Class II Terminated
FDA device recall Z-0471-2013 was initiated by Biomet, Inc. on Nov 1, 2012 and is designated Class II. 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. The recall status is terminated (terminated Apr 29, 2013). Affected quantity: 46.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 12, 2012
- Initiation Date
- Nov 1, 2012
- Termination Date
- Apr 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46
Product Description
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.
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.
Code Information
Part Numbers 32-472661 , 8.0 thru 12.5 Lot 013020, 050310, 056280, 154670, 418380, 691220, 755510, 860171, 866460
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0471-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026