Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Versatex Monofilament Mesh 50 x 50cm Recalled by Sofradim Production Due to There have been patient reports of abdominal hernia...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sofradim Production directly.
Affected Products
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.
Quantity: 703
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sofradim Production
Sofradim Production has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report