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Somatex Medical Technologies GMBH recalls Thread-like wire marker
Recalled March 17, 2021 · FDA recall Z-1200-2021 · Somatex Medical Technologies
Hazard
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. · FDA Class II
Units
196 pieces
Sold at
Domestic: Mo, NJ, OH
Description
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.
Product
Thread-like wire marker
Manufacturer(s)
Somatex Medical Technologies GMBH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →