March 12, 2025Medical DevicesFDA
TAS Medical Inc recalls TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Hazard: Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent surgery to correct a large herniation.