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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Orthopedics DCM AGC Molded Tibial Component

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  Class 2 Device Recall Biomet Orthopedics DCM AGC Molded Tibial Component see related information
Date Initiated by Firm July 24, 2007
Date Posted October 31, 2007
Recall Status1 Terminated 3 on July 24, 2008
Recall Number Z-0077-2008
Recall Event ID 44825
510(K)Number K921182  
Product Classification Knee Prosthesis - Product Code JWH
Product Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116.
Code Information Lot 918930; exp. 2012-02.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581-0587
For Additional Information Contact Paula Richardson
800-348-9500
Manufacturer Reason
for Recall		 Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm notified distributor by phone on or about 7/24/07 and followed up with an Urgent Medical Device Recall Notice/Letter dated 8/31/07. The letter requested that the product be discontinued and returned to Biomet.
Quantity in Commerce 1
Distribution Class II Recall - Worldwide Distribution --- USA including states of IA, SD, and countries of Brazil and Chile.
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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