CLASS II Device recall · Reported 17 Jul 2013 · FDA Enforcement Report

REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled

Biomet is recalling REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia, distributed in Indiana, North Carolina, Ohio, Pennsylvania. The recall was initiated on 7 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesM561250, M657110, M017540, M166880, M920640, M886440

Quantity recalled23

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1722-2013
FDA event ID: 65459
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 7 Jun 2013
FDA classified: 11 Jul 2013
Reported: 17 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

7 Jun 2013	Recall initiated by company
11 Jul 2013	Classified by FDA	+34 days
17 Jul 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 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.

Where it was distributed

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

Indiana North Carolina Ohio Pennsylvania

Questions about this recall

Is REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled?

Yes. Biomet recalled REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia on 7 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-1722-2013.

Why was it recalled?

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.

Which lots are affected?

M561250, M657110, M017540, M166880, M920640, M886440

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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