Somatex Medical Technologies GMBH recalls Thread-like wire marker

Recall date

February 3, 2021

Source

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

Recall number

Z-1200-2021

FDA classification

Class II

Brand / firm

Somatex Medical Technologies GMBH

Sold / distributed

Domestic: Mo, NJ, OH

Why it was recalled

This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body.

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

What was recalled

Thread-like wire marker