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Recall Observatory FDA recall evidence

Device product

Thread-like wire marker

Z-1200-2021

February 03, 2021

Class II

Product summary

Firm
Somatex Medical Technologies GMBH
Event
Event 87317
Status
Terminated
Classification
Class II
Quantity
196 pieces
Official record key
device-enforcement:Z-1200-2021

Official wording

Reason: 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.

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.

Distribution pattern: Domestic: Mo, NJ, OH

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.