Z-0267-2013 Class II Terminated
FDA device recall Z-0267-2013 was initiated by Medacta Usa Inc on October 13, 2008 and is designated Class II. 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 i… The recall status is terminated (terminated November 9, 2012). Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2012
- Initiation Date
- October 13, 2008
- Termination Date
- November 9, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
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)