FDA Medical Device Recalls (openFDA)
Biomet, Inc.: REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 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.
- Recall number
- Z-1723-2013
- Recalling firm
- Biomet, Inc.
- Product
- REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 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.
- Status
- Terminated
- Initiated
- 2013-06-07
- Posted
- 2013-07-11
- Terminated
- 2014-07-17
- 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 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
- 25
- Distribution
- Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
- Lot, serial or model codes
- M480960, M657120, M886450, M166890, M920650
- 510(k) numbers
- ["K122277"]
- PMA numbers
- not on file
- Product code
- HRY
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28