Class 2 Device Recall OSS Reamer Sleeve

• Date Initiated by Firm: November 01, 2012
• Date Posted: December 04, 2012
• Recall Status: Terminated on April 29, 2013
• Recall Number: Z-0471-2013
• Recall Event ID: 63612
• Product Classification: Reamer - Product Code HTO
• 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.
• Code Information: Part Numbers 32-472661 , 8.0 thru 12.5 Lot 013020, 050310, 056280, 154670, 418380, 691220, 755510, 860171, 866460
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: Audrey Daenzer; 574-372-1570
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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
• Quantity in Commerce: 46
• Distribution: Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.