Device product
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.
Z-0472-2013
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 63612
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36
- Official record key
device-enforcement:Z-0472-2013
Official wording
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.
Code information: Part Numbers 32-472662, 13.0 thru 20.0 Lot 154590, 156980, 519470, 519480, 542290, 628890, 755530
Distribution pattern: Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.
Derived failure modes
-
Unknown
Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.