Recall Z-1294-2025— TAS Medical Inc
Class II · Ongoing
Class II FDA medical device recall by TAS Medical Inc, initiated 2025-01-27. It names one FDA 510(k) clearance: K220980. Product: TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP. 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..
- Recalling firm
- TAS Medical Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-27
- Firm location
- Windermere, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.