Medacta Usa Inc: Medical Device Recall in 2013 - (Recall #: Z-0791-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.

Product Classification:

Class II

Date Initiated: December 17, 2012

Date Posted: February 13, 2013

Recall Number: Z-0791-2013

Event ID: 64160

Reason for Recall:

The tip of the Quadra Trial Broach size 0, broke during a surgery.

Status: Terminated

Product Quantity: 26 pieces U.S.A. (226 pieces Worldwide)

Code Information:

Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455

Distribution Pattern:

US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands

Voluntary or Mandated:

Voluntary: Firm initiated