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Terminated

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.

FDA Recall Z-0267-2013 · Posted 2012-11-08

Recalling FirmMedacta Usa Inc
Recall StatusTerminated
Product CodeJDI
Date Initiated2008-10-13
Date Terminated2012-11-09
Product Quantity12 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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