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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 Replacementsee related information
Date Initiated by FirmJune 07, 2013
Date PostedJuly 11, 2013
Recall Status1 Terminated 3 on July 17, 2014
Recall NumberZ-1701-2013
Recall Event ID 65459
510(K)NumberK122277 
Product Classification Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
ProductREF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 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 M619750 ; M375480; M886380, M956060 , M444700
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information ContactAudrey 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
ActionThe 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 Commerce24
DistributionWorldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HRY
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