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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Vanguard DCM CR Tibial Bearing

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  Class 2 Device Recall Biomet Vanguard DCM CR Tibial Bearing see related information
Date Initiated by Firm February 12, 2008
Date Posted July 25, 2008
Recall Status1 Terminated 3 on December 22, 2009
Recall Number Z-1376-2008
Recall Event ID 46708
510(K)Number K023546  
Product Classification Knee Prosthesis - Product Code JWH
Product Biomet Vanguard DCM CR Tibial Bearing, 14MM x 79/83MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183464.
Code Information Lot 743470.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581-0587
For Additional Information Contact Mary Hardesty
800-348-9500
Manufacturer Reason
for Recall		 Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure.
FDA Determined
Cause 2		 Packaging process control
Action Distributors were notified via recall letter (Urgent Medical Device Removal Notice) dated 2/12/08 to locate the devices in their possession and at hospital sites, discontinue use, and return them to Biomet. Hospitals having received the devices will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. A third letter dated 2/12/08 was provided for implanting physicians.
Quantity in Commerce 8
Distribution Worldwide: USA and Australia
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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