Osteomed, LLC recalls REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile

Recall date

May 31, 2023

Source

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

Recall number

Z-2107-2023

FDA classification

Class II

Brand / firm

Osteomed, LLC

Sold / distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG.

Why it was recalled

Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

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

What was recalled

REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile