FDA recall Z-1294-2025

TAS Medical Inc · Class II · device

Product

TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP

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.

Key facts

Status
Ongoing
Initiation date
2025-01-27
Report date
2025-03-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Windermere, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1294-2025