Date Initiated by Firm |
March 03, 2011 |
Date Posted |
April 28, 2011 |
Recall Status1 |
Terminated 3 on July 27, 2011 |
Recall Number |
Z-2140-2011 |
Recall Event ID |
58342 |
Product Classification |
knee prosthesis - Product Code JWH
|
Product |
Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141232, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement. |
Code Information |
REF 141232, LOT J100927055 |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582
|
For Additional Information Contact |
MARY JOHNSON 574-372-3983
|
Manufacturer Reason for Recall |
The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Biomet Orthopedics Inc initiated an electronic communication with Direct Accounts on March 3, 2011 and instructed them to quarantine and return all remaining/unused devices to the firm.
For questions regarding this recall call 574-372-3983. |
Quantity in Commerce |
8 |
Distribution |
Worldwide Distribution -USA including FL, IN, and NC and the countries of Japan and the Netherlands |
Total Product Life Cycle |
TPLC Device Report
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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.
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