Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall The Tissue Approximation System (TAS)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall The Tissue Approximation System (TAS)see related information
Date Initiated by FirmJanuary 27, 2025
Date PostedMarch 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1294-2025
Recall Event ID 96274
510(K)NumberK220980 
Product Classification Suture, nonabsorbable, synthetic, polyamide - Product Code GAR
ProductTISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Code Information 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)
Recalling Firm/
Manufacturer		 TAS Medical Inc
9100 Conroy Windermere Rd Ste 200
Windermere FL 34786-8431
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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 affected devices and insert the rehydration procedure into each of the remaining product boxes in your inventory at which point it can be released from quarantine. 3) Firm is is in the process of redesigning its packaging to prevent dehydration of the straps and will let you know when the new packaging is available. We anticipate that it may take up to six months to redesign the packaging, validate it, and release it to the field. Until then, the above rehydration procedure will restore the hydration to the straps in the surgical suite thereby preventing breakage that has been seen in the field. 4) Complete and return the acknowledgement and receipt form via email to tkramer@tasmedical.net Questions can be directed to the firm at (716) 997-2896 Monday through Friday between the hours of 8am and 5pm, EST.
Quantity in Commerce114
DistributionUS Nationwide distribution in the states of LA, OK, TN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GAR
-
-