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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 Recall
Biomet Orthopedics DCM AGC Molded Tibial Component
see related information
Date Posted October 31, 2007
Recall Status1 Terminated on July 24, 2008
Recall Number Z-0076-2008
Recall Event ID 44825
Premarket Notification
510(K) Number
K921182 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Biomet Orthopedic, Inc.
Code Information Lot 311500; exp. 2012-02.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 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
DESIGN: Component Design/Selection
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 4
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 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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