Date Initiated by Firm |
September 18, 2007 |
Date Posted |
November 24, 2007 |
Recall Status1 |
Terminated 3 on June 04, 2008 |
Recall Number |
Z-0255-2008 |
Recall Event ID |
45327 |
510(K)Number |
K915132
|
Product Classification |
Cruciate Tibial Plate - Product Code JWH
|
Product |
Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN 46582 |
Code Information |
Lot 626520. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46581-0587
|
For Additional Information Contact |
800-348-9500 Ext. 1305
|
Manufacturer Reason for Recall |
Mislabeled as to size: the package actaully contained a 71 mm tray.
|
FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Consignees were notified via letter dated 9/18/07 to discontinue use of the product and to return it to the firm. |
Quantity in Commerce |
7 |
Distribution |
Nationwide : Distributors in Georgia, Kentucky, Texas and Washington. |
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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