Medacta Usa Inc: Medical Device Recall in 2017 - (Recall #: Z-0266-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

Product Classification:

Class II

Date Initiated: October 24, 2017

Date Posted: December 27, 2017

Recall Number: Z-0266-2018

Event ID: 78401

Reason for Recall:

Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.

Status: Terminated

Product Quantity: 12,768 units

Code Information:

all serial numbers

Distribution Pattern:

nationwide

Voluntary or Mandated:

Voluntary: Firm initiated