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U.S. Department of Health and Human Services

Class 2 Device Recall Oxford Femoral Knee System

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  Class 2 Device Recall Oxford Femoral Knee System see related information
Date Initiated by Firm April 22, 2011
Date Posted June 29, 2011
Recall Status1 Terminated 3 on August 03, 2011
Recall Number Z-2698-2011
Recall Event ID 58702
510(K)Number K011138  
PMA Number P010014 
Product Classification Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
Product Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138)
This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.
Code Information REF 154600, LOT 2272736
Recalling Firm/
Manufacturer		 Biomet U.K., Ltd.
Waterton Industrial Estate
Bridgend, South Wales United Kingdom
Manufacturer Reason
for Recall		 This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device.
FDA Determined
Cause 2		 Packaging
Action Biomet sent a "FIELD SAFETY NOTICE" dated April 21, 2011, to all affected accounts. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product, locate and remove from inventory and quarantine pending return to their Bioment distributor. Customers were also instructed to complete and return the attached "Fax Back Response Form" to their local Biomet distributor. For questions customers should contact their local Biomet Contact.
Quantity in Commerce 12 devices
Distribution Outside the US to Austria, Belgium, and Germany
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 = HRY and Original Applicant = BIOMET, INC.
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