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U.S. Department of Health and Human Services

Class 2 Device Recall Oxford Fixed Bearing Partial Knee Replacement

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  Class 2 Device Recall Oxford Fixed Bearing Partial Knee Replacement see related information
Date Initiated by Firm June 07, 2013
Date Posted July 11, 2013
Recall Status1 Terminated 3 on July 17, 2014
Recall Number Z-1716-2013
Recall Event ID 65459
510(K)Number K122277  
Product Classification Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
Product REF 154229 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size E4 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R

The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code Information M561240, M632960 , M136950 M657040 , M722420 , M444890
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
FDA Determined
Cause 2
Device Design
Action The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated June 7, 2013 to its consignees/customers. The letter identified the device being recalled, the reason for the recall, potential adverse events associated with the recall and actions to be taken. The consignees/customers were instructed immediately locate and remove the identified device(s) listed in the letter; carefully follow the instructions on the enclosed "FAX Back Response Form"; complete and return the FAX Back Response Form to 574-372-1683 prior to return of product within three (3) business days; return Goods to Biomet, Inc 56 East Bell Drive Warsaw, IN 46580. To confirm receipt of this notice by call 574-372- 1570. Obtain an RGA # by phone (574)372-6677 email rqarequest@biomet.com or through FAST; use priority carrier for your shipment; and if you have further distributed this product you MUST notify personnel of the letter. Questions should be addressed to 574-372-1570 M-F 8 a.m. to 5 p.m.
Quantity in Commerce 25
Distribution Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and 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 = HRY and Original Applicant = BIOMET MANUFACTURING CORP.
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