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.
FDA Recall Z-1523-2018 · Posted 2018-04-26
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Recalling FirmSofradim Production
Recall StatusTerminated
Product CodeFTL
Date Initiated2018-02-23
Date Terminated2020-05-12
Product Quantity703
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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