Sofradim Versatex Monofilament Mesh Recalled for Hernia Recurrence Reports
Sofradim Production is recalling Versatex Monofilament Mesh due to patient reports of abdominal hernia recurrence following repair. The firm has updated instructions to warn surgeons about risks in specific procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury (hernia recurrence) has been reported, but no fatalities or severe injuries are explicitly stated, fitting the High severity criteria.
Plain-English summary
Sofradim Production is recalling 703 units of Versatex Monofilament Mesh 50 x 50cm (Product No. VTX5050M). This medical device is a macroporous three-dimensional monofilament polyester textile intended for the repair of abdominal wall hernias or other fascial deficiencies that require reinforcing material.
The recall was initiated following patient reports of abdominal hernia recurrence after hernia repair. In response, the recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of the risks associated with using the device in Transversus Abdominis Muscle Release (TAR) procedures.
The affected units were distributed nationwide in the United States 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. The devices were also distributed to Belgium, Finland, France, Germany, Ireland, Israel, Italy, the Netherlands, the Russian Federation, Spain, Switzerland, and the UK. Healthcare providers should review the updated Instructions for Use and contact the manufacturer for further information.
The recalled product
- 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…
- Manufacturer
- Sofradim Production
- Category
- Medical Device — Surgical Mesh
- Hazard
- Affected units
- 703
Distribution
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