Medical Device Recall: TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
TAS Medical Inc · January 27, 2025
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of LA, OK, TN.
States Affected
NATIONWIDE
Quantity Affected
114
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1294-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.