Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

TISSUE APPROXIMATION SYSTEM (TAS) Recalled by TAS Medical Inc Due to Tissue approximation straps (zip-ties) have broken before or...

Date: January 27, 2025
Company: TAS Medical Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact TAS Medical Inc directly.

Affected Products

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

Quantity: 114

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About TAS Medical Inc

TAS Medical Inc has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report