Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM

Recall date

August 7, 2017

Source

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

Recall number

Z-0424-2018

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

US nationwide distribution. Also Portugal and the Netherlands.

Why it was recalled

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

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

What was recalled

Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM