Somatex Medical Technologies GMBH: Medical Device Recall in 2021 - (Recall #: Z-1200-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Thread-like wire marker

Product Classification:

Class II

Date Initiated: February 3, 2021

Date Posted: March 17, 2021

Recall Number: Z-1200-2021

Event ID: 87317

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.

Status: Terminated

Product Quantity: 196 pieces

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

Voluntary or Mandated:

Voluntary: Firm initiated