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U.S. Department of Health and Human Services

Class 2 Device Recall Orthopedic Salvage System NonModular Tibial Base, Long

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  Class 2 Device Recall Orthopedic Salvage System NonModular Tibial Base, Long see related information
Date Initiated by Firm November 07, 2007
Date Posted September 17, 2008
Recall Status1 Terminated 3 on March 13, 2009
Recall Number Z-2214-2008
Recall Event ID 45806
510(K)Number K052685  
Product Classification Hip Prosthesis metal/polymer semi-constrained cemented - Product Code JDI
Product Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, 75mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161044.

Implant is part of a system used to replace the tibial portion of the knee joint.
Code Information Lots 173950, Exp 09/2016; 188380, Exp 09/2016; 459420, Exp 11/2016; 534920, Exp 04/2017 and 802650, Exp 12/2016.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581-0587
For Additional Information Contact
800-348-9500 Ext. 1305
Manufacturer Reason
for Recall		 Mislabeled as to size: Product is labeled as reduced size, but is actually standard size.
FDA Determined
Cause 2		 Labeling mix-ups
Action Consignees were notified by an Urgent Medical Device Recall Notice letter dated 11/7/07. The letter required that use of the product be immediately discontinued and that components be returned to Biomet. Letters to hospital administrators and the five implanting surgeons were issued on/or about 5/6/08 advising them of the problem and to perform patient evaluations.
Quantity in Commerce 22
Distribution Nationwide Distribution --- including states of California, Florida, Illinois, Indiana, Massachusetts, Missouri, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington.
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 = JDI and Original Applicant = BIOMET, INC.
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