Z-1716-2013Class II

REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy...

Name: Z-1716-2013 REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy...
Creator: Biomet, Inc.
Published: 2013-06-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-06-07 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The... on 2013-06-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1716-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-07
Posted: 2013-07-11
Terminated: 2014-07-17
Recalling firm: Zimmer GmbH
Product: REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 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.
Product code: HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
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.
Root cause tag: design
FDA 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 [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.
Quantity in commerce: 25
Distribution: Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
Product codes and lots: M561240, M632960 , M136950 M657040 , M722420 , M444890

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1716-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1695-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1696-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1697-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1698-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1699-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1700-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1701-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1702-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1703-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1704-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1705-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1706-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1707-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1708-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1709-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1710-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1711-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1712-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1713-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1714-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1715-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1716-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1717-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1718-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1719-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1720-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1721-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1722-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1723-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11
Z-1724-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11

Product code HRY

K122277Class IIOxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford Partial Knee Replacement SystemBiomet Manufacturing Corp / cleared 2012-10-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)