REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 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.
FDA Recall Z-1718-2013 · Posted 2013-07-11
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHRY
Date Initiated2013-06-07
Date Terminated2014-07-17
Product Quantity28
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.
Firm 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 [email protected] 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.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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