Home / Recalls / Somatex Medical Technologies GMBH / Z-1200-2021

Z-1200-2021 Class II Terminated

Recalled by Somatex Medical Technologies GMBH — Berlin

Recall Details

Product Type: Devices
Report Date: March 17, 2021
Initiation Date: February 3, 2021
Termination Date: January 13, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 196 pieces

Product Description

Thread-like wire marker

Reason for Recall

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.

Distribution Pattern

Domestic: Mo, NJ, OH

Code Information

Tuflex: REF 271640 Affected Lots: 51268, 51414; REF 271641 Affected Lots: 51269, 51410; REF 271642 Affected Lots: 51270, 51411; REF 271643 Affected Lots: 51271, 51412. Tuflex Premium: REF 271650 Affected Lots: 51300; REF 271651 Affected Lots: 51299, 51413; REF 271652 Affected Lots: 51301.