Medacta Usa Inc recalls The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number…

Recall date

October 24, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0266-2018

FDA classification

Class II

Brand / firm

Medacta Usa Inc

Sold / distributed

nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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