PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 12, 2012 Initiated: November 1, 2012 #Z-0472-2013

Product Description

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.

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.

Details

Recalling Firm
Biomet, Inc.
Units Affected
36
Distribution
Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Biomet, Inc.. Units affected: 36.
Why was this product recalled?
Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 12, 2012. Severity: Moderate. Recall number: Z-0472-2013.