FDA-Device2025-03-12Class II
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
TAS Medical Inc
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.
Sold states
US Nationwide distribution in the states of LA, OK, TN.
Affected count
114
Manufactured in
9100 Conroy Windermere Rd Ste 200, Windermere, FL, United States
Products
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1294-2025Don't want to check this manually?
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