Z-1294-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2025
- Initiation Date
- January 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114
Product Description
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 Pattern
US Nationwide distribution in the states of LA, OK, TN.
Code Information
Model/UDI-DI/Lot(Expiration): T-4000/00197644217267/230403(2024/04/20); T-5000/00860011435921/240801(2025/08/28), 240901(2025/09/25); T-LAP/00860011435914, 00197644927241/240702(2025/07/08), 230906(2024/11/29), 230905(2024/11/29)