Date Initiated by Firm |
July 24, 2007 |
Date Posted |
October 31, 2007 |
Recall Status1 |
Terminated 3 on July 24, 2008 |
Recall Number |
Z-0076-2008 |
Recall Event ID |
44825 |
510(K)Number |
K921182
|
Product Classification |
Knee Prosthesis - 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 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 |
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 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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