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U.S. Department of Health and Human Services

Class 2 Device Recall Broach Handle, manual orthopedic surgical instrument

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 Class 2 Recall
Broach Handle, manual orthopedic surgical instrument
see related information
Date Posted November 08, 2012
Recall Status1 Terminated on November 09, 2012
Recall Number Z-0267-2013
Recall Event ID 53337
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
Product 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.
Code Information 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)
Recalling Firm/
Manufacturer
Medacta Usa Inc
4725 Calle Quetzal Unit B
Camarillo, California 93012-9101
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Medacta USA, sent a Urgent Safety Notification letter dated October 13, 2008, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The letter informed the customers of the lot numbers on recall and the reference numbers. The recall was initiated because the offset broach handles contain a lever mechanism that is connected to the locking axis by means of a metallic wire. 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. For further questions please call (858) 705-0350.
Quantity in Commerce 12 units
Distribution Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
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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