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Sofradim Production Recalls

1 recall on record · May 2, 2018 to May 2, 2018 · Medical Devices

May 2, 2018Medical DevicesFDA

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

Hazard: 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.

Sofradim Production Recalls | RecallWatchUSA