TAS Medical Inc: Device Recall
Recall #Z-1294-2025 · 01/27/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1294-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- TAS Medical Inc
- Status
- Ongoing
- Date Initiated
- 01/27/2025
- Location
- Windermere, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114
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.
Product Description
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Distribution Pattern
US Nationwide distribution in the states of LA, OK, TN.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.