Synthes (USA) Products LLC recalls Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary a…

Recall date

December 29, 2016

Source

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

Recall number

Z-1124-2017

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

United States Nationwide Distribution.

Why it was recalled

There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.

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

What was recalled

Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.