Sofradim Production recalls Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional mo…

Recall date

February 23, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1523-2018

FDA classification

Class II

Brand / firm

Sofradim Production

Sold / distributed

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, Sw…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.