Z-0410-2018Class II

TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE

Name: Z-0410-2018 TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
Creator: Somatex Medical Technologies GmbH
Published: 2017-05-22
License: https://open.fda.gov/license/

SOMATEX Medical Technologies GmbH / initiated 2017-05-22 / Terminated / root cause: design

FDA source

Somatex Medical Technologies GmbH began a recall of TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE on 2017-05-22. FDA classified it as Class II and gives the reason as "There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile". 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-0410-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Posted: 2018-01-24
Terminated: 2018-08-30
Recalling firm: SOMATEX Medical Technologies GmbH
Product: TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
Product code: NEU Marker, Radiographic, Implantable
Reason for recall: There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.
Root cause tag: design
FDA root cause: Device Design
Action: On May 22, 2017, Somatex Medical Technologies distributed notices to their customers advising them of the reason for recall. Customers are advised to inspect stock, quarantine and not use affected product. Products will be exchanged free of charge and a replacement delivery will be arranged promptly. All customers are expected to complete and return the response form via fax.
Distribution: NY - Only one US distributor
Product codes and lots: Lot numbers: 47883, 47910 & 47911

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0410-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0410-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-24

Product code NEU

K073095Class IITumark Professional, Model 271560; Mr- Tumark Professional, Model 601560Somatex Medical Technologies GmbH / cleared 2008-03-19

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)