Date Initiated by Firm | October 13, 2008 |
Date Posted | November 08, 2012 |
Recall Status1 |
Terminated 3 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
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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 CA 93012-9101
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For Additional Information Contact | 858-705-0350 |
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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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