Medacta Usa: Medical Device Recall in 2014 - (Recall #: Z-0202-2015)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2014.
Data Source: FDA.
Product Description:
GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.
Product Classification:
Class II
Date Initiated: September 22, 2014
Date Posted: November 19, 2014
Recall Number: Z-0202-2015
Event ID: 69493
Reason for Recall:
Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
Status: Terminated
Product Quantity: 1 rod (US); 145 rods (global)
Code Information:
Model Number: 02.07.10.0162
Distribution Pattern:
Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.
Voluntary or Mandated:
Voluntary: Firm initiated