FDA-Device2013-04-24Class II
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.
Biomet U.K., Ltd.
Hazard
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.
Sold states
Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.
Affected count
430
Manufactured in
Waterton Industrial Estate, N/A, Bridgend South Wales, N/A, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1124-2013Don't want to check this manually?
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