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

REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled

Biomet is recalling REF 154223 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 codesM300790, M632920, M539410, M444850, M987620, M987310

Quantity recalled46

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-1712-2013
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: Other Reasons
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.

Product as listed by the FDA

REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 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

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?

M300790, M632920, M539410, M444850, M987620, M987310

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

Other products in this recall event

29 other products · FDA event 65459

This product is part of a recall event; the main page for the event is REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled.

Reported	Class	Recall	Company	Reason	Where
17 Jul 2013	CLASS II	REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states
17 Jul 2013	CLASS II	REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia recalled	Biomet	Other	4 states

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