Recall Z-1711-2013 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Biomet, Inc.
REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 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 t
| Date | Jul 11, 2013 (initiated Jun 7, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 Goo |
| Quantity | 37 |
| Distribution | Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122277 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM Biomet Manufacturing Corp, Oct 22, 2012 |