Arthrex, Inc. recalls Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a…

Recall date

June 24, 2020

Source

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

Recall number

Z-2733-2020

FDA classification

Class II

Brand / firm

Arthrex, Inc.

Sold / distributed

International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands

Why it was recalled

Screws provided in packaging are 5mm shorter 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

Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.