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U.S. Department of Health and Human Services

Class 2 Device Recall OSS (Orthopedic Salvage System) NonModular Tibial Base Long

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 Class 2 Device Recall OSS (Orthopedic Salvage System) NonModular Tibial Base Longsee related information
Date Initiated by FirmNovember 07, 2007
Date PostedSeptember 17, 2008
Recall Status1 Terminated 3 on March 13, 2009
Recall NumberZ-2213-2008
Recall Event ID 45806
510(K)NumberK052685 
Product Classification Knee Prosthesis Femortibial metal/polymer - Product Code KRO
ProductOSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is part of a system used to replace the tibial portion of the knee joint.
Code Information Lots 053850, Exp 08/2016; 070890, Exp 08/2016; 201930, Exp 09/2016; 364790, Exp 10/2016; 507290, Exp 11/2016 and 534910, Exp 04/2017.
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
ActionConsignees 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 Commerce22
DistributionNationwide Distribution --- including states of California, Florida, Illinois, Indiana, Massachusetts, Missouri, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KRO
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