Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the s

FDA device recall Z-0267-2013 · posted 2012-11-08 · Terminated

Recall details

Recalling firm

Medacta Usa Inc

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.

Action taken

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

Status

Terminated

Product code

JDI

Quantity affected

12 units

Distribution

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

Date initiated

2008-10-13

Date posted

2012-11-08

Date terminated

2012-11-09

Location

Camarillo, CA