Windermere, FL, United States
TAS Medical Inc recalls
1 recall recorded since 2018, most recently on 27 January 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 January 2025
- Reason
- 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
- US Nationwide distribution in the states of LA, OK, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1294-2025
- TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.