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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Event Detail

Event ID 53337
Product Type Devices
Status Completed
Recalling Firm Medacta Usa Inc
City Camarillo
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-10-13
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem. Ref: 01.10.10.122 (Lot # 085119), Ref: 01.10.10.123 (Lot # 085120), Ref: 01.10.10.124 (Lot # 085244), Ref: 01.10.10.125 (Lot # 085243) Class II Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches. 12 units Z-0267-2013
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