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U.S. Department of Health and Human Services

Class 2 Device Recall OSS Reamer Sleeve

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 Class 2 Recall
OSS Reamer Sleeve
see related information
Date Posted December 04, 2012
Recall Status1 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, Indiana 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 2
DESIGN: Process Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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