Recall Z-1124-2013— Biomet U.K., Ltd.
Class II · Terminated
Class II FDA medical device recall by Biomet U.K., Ltd., initiated 2013-03-20, terminated 2015-05-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Biomet U.K., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-20
- Terminated
- 2015-05-04
- Firm location
- Bridgend South Wales, N/A, United Kingdom
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.