Synthes (USA) Products LLC recalls 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Scr…

Recall date

September 12, 2018

Source

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

Recall number

Z-0238-2019

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.

Why it was recalled

The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.

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

What was recalled

3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.