Recall Z-0471-2013— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2012-11-01, terminated 2013-04-29. FDA's recall record names no specific 510(k) clearance for this event. 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: Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-01
- Terminated
- 2013-04-29
- Firm location
- Warsaw, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.