Z-1200-2021Class II

Thread-like wire marker

Name: Z-1200-2021 Thread-like wire marker
Creator: Somatex Medical Technologies GMBH
Published: 2021-02-03
License: https://open.fda.gov/license/

SOMATEX Medical Technologies GmbH / initiated 2021-02-03 / Terminated / root cause: design

FDA source

Somatex Medical Technologies GMBH began a recall of Thread-like wire marker on 2021-02-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1200-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-03
Posted: 2021-03-10
Terminated: 2022-01-13
Recalling firm: SOMATEX Medical Technologies GmbH
Product: Thread-like wire marker
Product code: MIJ Needle, Tumor Localization
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 196 pieces
Distribution: Domestic: Mo, NJ, OH
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1200-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1200-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-10

Product code MIJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)