FDAClass IIJuly 17, 2013

REF 154207 Oxford Fixed Bearing recall

REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile…

Why was REF 154207 Oxford Fixed Bearing 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

M561220 M584370 M151880 , M444690, M886370 , M956050,

Product
REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile…
Recalling firm
Biomet, Inc.
Quantity
25
Distribution
Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
Recall date
July 17, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls