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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
OSS Knee Reamer Sleeves		see related information
Date Posted December 05, 2012
Recall Number Z-0474-2013
Product Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: 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 Catalog Number: 113740 and Lot Number Identification: 779270
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
Consumer Instructions Contact the recalling firm for information
Reason for
Recall		 The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.
Action Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 1, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The notification letter instructed the surgeon to montior the patient as their is a potential for increased wear which have an unknown effect on implant life. For questions call 574-372-1570.
Quantity in Commerce 4
Distribution USA Nationwide Distribution in the state of WI.
 
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