FDAFDA · Food and drugs·Recall number Z-0472-2013
OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 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.
Published December 12, 2012 · Recall initiated: November 1, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.
- Lot
- Part Numbers 32-472662, 13.0 thru 20.0 Lot 154590, 156980, 519470, 519480, 542290, 628890, 755530
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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