CLASS II Device recall · Reported 22 Jul 2015 · FDA Enforcement Report

Oxford Femoral Drill Guide Lateral IM Adapter recalled by Biomet

Biomet is recalling Oxford Femoral Drill Guide Lateral IM Adapter, distributed nationwide in the US. The recall was initiated on 3 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 32-423400 Lot Numbers: 238220, 664720,489620, 490930,021410, 507150

Quantity recalled18

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-2065-2015
FDA event ID: 71529
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 3 Jun 2015
FDA classified: 14 Jul 2015
Reported: 22 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

3 Jun 2015	Recall initiated by company
14 Jul 2015	Classified by FDA	+41 days
22 Jul 2015	Published in enforcement report	+8 days

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

Reason for recall

Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link.

Product as listed by the FDA

Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. 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. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. 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 - US Nationwide in the states of NC, IN, PA, OH and the country of the Netherlands.

Nationwide Indiana North Carolina Ohio Pennsylvania

Questions about this recall

Why was it recalled?

Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link.

Which lots are affected?

Part Number: 32-423400 Lot Numbers: 238220, 664720,489620, 490930,021410, 507150

Where was it sold?

Worldwide Distribution - US Nationwide in the states of NC, IN, PA, OH and the country of the 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.

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