Agency classClass IIOur severity:High FDA (Devices)·Z-1124-2013·Announced 2013-04-24

Biomet Oxford Uni Knee System Toffee Hammer Recalled for Weld Cracking

Biomet U.K., Ltd. is recalling 430 Oxford Uni Knee System Toffee Hammers because excessive use may cause the head to detach from the handle.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect (weld cracking) that could cause a part to detach, posing a risk of harm to patients or surgeons, but the source does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomet U.K., Ltd. is recalling 430 units of the Oxford Uni Knee System Toffee Hammer (REF 32-422760). This non-sterile surgical instrument is supplied as part of the Oxford Microplasty Knee System Tibial Instrument Tray (REF 32-422763) and is used for impacting implants. The affected units were distributed worldwide, including in the United States, Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.

The recall was initiated after an investigation of complaints revealed that excessive use of the instrument could result in cracking on the weld between the head and the handle. This defect could lead to part of the head becoming detached from the handle during use.

Healthcare facilities and distributors should stop using the affected instruments and contact Biomet U.K., Ltd. for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

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 surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.
Manufacturer: Biomet U.K., Ltd.
Category: Medical Device — Surgical Instrument
Hazard: structural-defect
part-detachment
Affected units: 430

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · Biomet U.K., Ltd.

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Biomet Recalls Oxford Partial Knee Instruments Due to Material Inclusions
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Same hazard · structural defect