REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use i

FDA device recall Z-1704-2013 · posted 2013-07-11 · Terminated

Recall details

Recalling firm

Biomet, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

HRY

Quantity affected

22

Distribution

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

Date initiated

2013-06-07

Date posted

2013-07-11

Date terminated

2014-07-17

Location

Warsaw, IN

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