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U.S. Department of Health and Human Services

Class 2 Device Recall Vanguard

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  Class 2 Device Recall Vanguard see related information
Date Initiated by Firm April 20, 2010
Date Posted August 10, 2010
Recall Status1 Terminated 3 on January 19, 2011
Recall Number Z-2204-2010
Recall Event ID 55909
510(K)Number K023546  
Product Classification knee prosthesis - 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 IN 46582
For Additional Information Contact
574-267-6639 Ext. 1676
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		 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 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 = JWH and Original Applicant = BIOMET, INC.
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