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Recall Observatory FDA recall evidence

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

October 13, 2008

Class II

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

    reason.no_named_rule · v1.0.0

    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.