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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 64679
Product Type Devices
Status Ongoing
Recalling Firm Biomet U.K., Ltd.
City Bridgend, South Wales
Country GB
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-20
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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 Class II 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. 430 Z-1124-2013