medical Class II Updated 2025-03-12

TAS Medical Inc recalls TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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)
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