Recall Z-1294-2025 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
TAS Medical Inc
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
| Date | Mar 6, 2025 (initiated Jan 27, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On 1/27/2025, correction notices were emailed to customers who were asked to do the following: 1) Firm has developed and validated an interim method for conditioning the product in the surgical suite just prior to implantation to rehydrate the zip-tie straps per these instructions. To reverse the effects of dehydration, when preparing for surgery, submerge the TAS zip-tie straps in 40-degreesC (104-degrees F) sterile saline solution for 60 minutes prior to implantation. The orange leader material is not subject to dehydration and therefore is not required to be soaked. 2) Quarantine affec |
| Quantity | 114 |
| Distribution | US Nationwide distribution in the states of LA, OK, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220980 | Tissue Approximation System (TAS) Tas Medical, Inc., Jul 5, 2023 |