Arthrex, Inc. recalls Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of…

Recall date

October 1, 2019

Source

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

Recall number

Z-1510-2020

FDA classification

Class II

Brand / firm

Arthrex, Inc.

Sold / distributed

US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China

Why it was recalled

Screws provided in the device package are 6 mm longer than intended.

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

What was recalled

Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.