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.
Recall
- Recall Number
- Z-0471-2013
- Event Number
- 63612
- Firm
- Biomet, Inc.
- FEI Number
- 1825034
- Product Code
- HTO
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 1, 2012
- Posted
- December 4, 2012
- Terminated
- April 29, 2013
- Address
- 56 E Bell Dr, Warsaw, IN, 46582-6989
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.
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 firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated November 1, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately locate, discontinue use of and remove the product from circulation; and return recalled devices with directions to distribute notices, if product was further distributed; and to complete and return the enclosed FAX Back Response Form within three (3) business days to FAX # 574-372-1683. Distributors were charged with locating and returning products to Biomet ATTN: Return Goods-Building B RECALLS RGA#: _, Biomet, Inc., 56 East Bell Drive, Warsaw, IN 46580. Questions should be directed to the Field Action Coordinator at (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m
Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.
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