FDADecember 29, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

synthes usa productssynthessynthes usa

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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