FDA-Device2021-03-17Class II
Thread-like wire marker
Somatex Medical Technologies GMBH
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.
Sold states
Domestic: Mo, NJ, OH
Affected count
196 pieces
Manufactured in
Hohenzollerndamm 150-151, Berlin, Germany
Products
Thread-like wire marker
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1200-2021Don't want to check this manually?
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