Medacta Usa: Medical Device Recall in 2015 - (Recall #: Z-0275-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery

Product Classification:

Class II

Date Initiated: April 17, 2015

Date Posted: November 25, 2015

Recall Number: Z-0275-2016

Event ID: 71121

Reason for Recall:

Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.

Status: Terminated

Product Quantity: 4 units (US)

Code Information:

Lot: 145129

Distribution Pattern:

Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated