Device 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.
Z-0267-2013
Product summary
- Firm
- Medacta Usa Inc
- Event
- Event 53337
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-0267-2013
Official wording
Reason: 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.
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)
Distribution pattern: Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
Derived failure modes
-
Unknown
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.