Tissue Approximation System recall
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Why was Tissue Approximation System 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
- Recalling firm
- TAS Medical Inc
- Quantity
- 114
- Distribution
- US Nationwide distribution in the states of LA, OK, TN.
- Recall date
- March 12, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)