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

Recall date

January 27, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1294-2025

FDA classification

Class II

Brand / firm

TAS Medical Inc

Sold / distributed

US Nationwide distribution in the states of LA, OK, TN.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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