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Recall Observatory FDA recall evidence

Device 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.

Z-1124-2013

March 20, 2013

Class II

Product summary

Firm
Biomet U.K., Ltd.
Event
Event 64679
Status
Terminated
Classification
Class II
Quantity
430
Official record key
device-enforcement:Z-1124-2013

Official wording

Reason: 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.

Code information: 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 pattern: Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.