FDAClass IIApril 24, 2013

REF 32-422760 Oxford Uni Knee System recall

REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small…

Why was REF 32-422760 Oxford Uni Knee System recalled?

Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle.

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?

32-422760 ( sold as part of instrument set 32-422763 ) ZB100901,ZB110201,ZB110301,ZB110302,ZB110303, ZB110304,ZB110601,ZB110602,ZB110701,ZB111201, ZB111202,ZB120201,ZB120202,ZB120701,ZB120801, ZB120802,ZB121102,ZB121103

Product
REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small…
Recalling firm
Biomet U.K., Ltd.
Quantity
430
Distribution
Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.
Recall date
April 24, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls