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U.S. Department of Health and Human Services

Class 2 Device Recall Vanguard

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 Class 2 Recall
Vanguard
see related information
Date Posted August 10, 2010
Recall Status1 Terminated on January 19, 2011
Recall Number Z-2204-2010
Recall Event ID 55909
Premarket Notification
510(K) Number
K023546 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.
Code Information M402080.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582
Manufacturer Reason
for Recall
A knee implant labeled as left was opened and the package actually contained a right knee implant.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer.
Quantity in Commerce 5
Distribution 1 unit in US. 3 units in Biomet distributor inventory, 1 unit in Japan
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = BIOMET, INC.
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