Z-1523-2018Class II

Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous...

Name: Z-1523-2018 Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous...
Creator: Sofradim Production
Published: 2018-02-23
License: https://open.fda.gov/license/

Sofradim Production / initiated 2018-02-23 / Terminated / root cause: labeling and UDI

FDA source

Sofradim Production began a recall of Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its... on 2018-02-23. FDA classified it as Class II and gives the reason as "There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1523-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-23
Posted: 2018-04-26
Terminated: 2020-05-12
Recalling firm: Sofradim Production
Product: Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: All consignees were notified via Federal Express or certified mail on February 23, 2018. Customers were advised of the added warning on the product labeling. Customers were requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. Customers with questions were directed to contact their Medtronic Representative, or Customer Service at 800-962-9888, option 2.
Quantity in commerce: 703
Distribution: Worldwide Distribution - USA (nationwide) Distribution to the states of: CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, PA, TN, TX, VA, WA and WI, and to the countries of : Belgium, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, Russian Federation, Spain, Switzerland, and UK.
Product codes and lots: UDI - 10884521532298 Lots SPC1091X SPJ0706X SPJ1016X SQA0990X SQI0302X SQJ0443X SQK0319X SRA2188X SRI0548X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1523-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1523-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-26

Product code FTL

K150091Class IIVersatex Monofilament MeshSofradim Production / cleared 2015-05-26

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)