Encore Medical, Lp recalls RSP Impaction Fixture

Recall date

February 9, 2017

Source

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

Recall number

Z-1413-2017

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany

Why it was recalled

During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.

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

What was recalled

RSP Impaction Fixture