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U.S. Department of Health and Human Services

Class 2 Device Recall OSS Knee Reamer Sleeves

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  Class 2 Device Recall OSS Knee Reamer Sleeves see related information
Date Initiated by Firm November 01, 2012
Date Posted December 05, 2012
Recall Status1 Terminated 3 on August 29, 2013
Recall Number Z-0474-2013
Recall Event ID 63708
510(K)Number K030710  
Product Classification Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
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 IN 46582-6989
For Additional Information Contact
574-267-6639 Ext. 1676
Manufacturer 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.
FDA Determined
Cause 2		 Process control
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.
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.
510(K) Database 510(K)s with Product Code = KWT and Original Applicant = BIOMET, INC.
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