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U.S. Department of Health and Human Services

Class 2 Device Recall Oxford Unicompartmental Toffee Hammer

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 Class 2 Recall
Oxford Unicompartmental Toffee Hammer
see related information
Date Posted April 15, 2013
Recall Status1 Open
Recall Number Z-1124-2013
Recall Event ID 64679
Product Classification Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing - Product Code NRA
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.
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
Recalling Firm/
Manufacturer
Biomet U.K., Ltd.
Waterton Industrial Estate
Bridgend, South Wales
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
Action BIOMET sent an Urgent Medical Device Recall Notice on March 20, 2013, to all affected customers with directions to forward the notice if product was further distributed to Hospital Operating Room managers. The notice identified the recalled device, reason for the recall, and possible adverse events directing consignees to locate and discontinue use of the device. A FAX back Response form was to be returned to 574-372-1683 within 3 days of receipt prior to return of the product to Biomet, USA. Questionsregarding this recall should be addressed to 574 372-1570 M-F, 8a.m. -5 p.m.
Quantity in Commerce 430
Distribution Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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