TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP

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.

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 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 [email protected] Questions can be directed to the firm at (716) 997-2896 Monday through Friday between the hours of 8am and 5pm, EST.