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Terminated

Thread-like wire marker

FDA Recall Z-1200-2021 · Posted None

Recalling FirmSomatex Medical Technologies GMBH
Recall StatusTerminated
Product CodeMIJ
Date Initiated2021-02-03
Date Terminated2022-01-13
Product Quantity196 pieces

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.

Firm Action

On 1/22/2021, Somatex issued an Urgent Medical Device Removal notice to customers via e-mail for Tuflex and Tuflex Premium marking wires. This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion.

Root Cause

Device Design

Distribution Pattern

Domestic: Mo, NJ, OH

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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