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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Oxford Unicompartmental Knee

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 Class 2 Recall
Biomet Oxford Unicompartmental Knee
see related information
Date Posted February 03, 2009
Recall Status1 Terminated on July 07, 2009
Recall Number Z-0962-2009
Recall Event ID 50699
Premarket Approval
PMA Number
P010014
Product Classification Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing - Product Code NRA
Product Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, CoCr, sterile, Biomet UK Ltd, Bridgend, UK; . Unicompartmental knee joint replacement system. Designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis.
Code Information Lot 1563796.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582
Manufacturer Reason
for Recall
Packages labeled as "right" actually contain a "left" component.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Biomet salesmen were notified by phone and instructed to retrieve the products. One customer was notified by letter dated 12/19/08 that use of the product should cease and that a salesman would pick up the product. A second customer had implanted the product and was hand delivered a letter dated 12/19/08 instructing that the patient should be monitored and symptoms treated as necessary. Contact Biomet at 574-362-3983 for assistance.
Quantity in Commerce 2
Distribution Massachusetts and West Virginia.
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.
PMA Database PMAs with Product Code = NRA and Applicant = BIOMET
PMAs with Product Code = NRA and Applicant = BIOMET MANUFACTURING CORP.
PMAs with Product Code = NRA and Applicant = BIOMET ORTHOPEDICS, INC.
PMAs with Product Code = NRA and Applicant = BIOMET, INC.
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