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.
Check against the official notice below — it lists the full affected range.
Sofradim Production is recalling Versatex Monofilament Mesh (50 x 50cm, Product No. VTX5050M), a polyester mesh device used in hernia repair surgery. The recall was initiated because patients have experienced abdominal hernia recurrence following hernia repair procedures performed with this device. In response, the manufacturer has added a statement to the device's Instructions for Use to alert surgeons about the risks of using this mesh in Transversus Abdominis Muscle Release (TAR) procedures.
The recalled mesh was distributed worldwide, including to 24 U.S. states and 12 countries in Europe and the Middle East. A total of 703 units across 10 lot numbers are affected, identified by UDI 10884521532298 and lot codes including SPC1091X, SPJ0706X, SPJ1016X, SQA0990X, SQI0302X, SQJ0443X, SQK0319X, SRA2188X, and SRI0548X. The recall record does not specify what remedy an affected consumer should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 703 Lot/code info: UDI - 10884521532298 Lots SPC1091X SPJ0706X SPJ1016X SQA0990X SQI0302X SQJ0443X SQK0319X SRA2188X SRI0548X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.