Medacta Usa Inc: Medical Device Recall in 2012 - (Recall #: Z-0267-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 13, 2008

Date Posted: November 14, 2012

Recall Number: Z-0267-2013

Event ID: 53337

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.

Status: Terminated

Product Quantity: 12 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated