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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet CC IBeam Tibial Plate 75mm

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  Class 2 Device Recall Biomet CC IBeam Tibial Plate 75mm see related information
Date Initiated by Firm March 03, 2011
Date Posted April 28, 2011
Recall Status1 Terminated 3 on July 27, 2011
Recall Number Z-2104-2011
Recall Event ID 58342
510(K)Number K915132  
Product Classification Prosthesis, knee - Product Code JWH
Product Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141224, 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 141224, LOT J100921070
Recalling Firm/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact MARY JOHNSON
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

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.