Recall Z-1891-2024 ยท GDW Staple, Implantable
Covidien, LP
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
| Date | May 24, 2024 (initiated Apr 15, 2024) |
| Status | Open, Classified |
| Reason | Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery |
| Root cause | Under Investigation by firm |
| Action | Medtronic issued Urgent Medical Device Recall letter on 4/15/24 via UPS 2-day. Letter states reason for recall, health risk and action to take: Customer Actions: " Immediately identify and quarantine all unused Tri-Staple" 2.0 Black Reinforced Intelligent Reload, Model SIGTRSB60AXT, from the specified lot(s) mentioned above. " Return all unused product in your inventory, corresponding to the specified lot(s) mentioned above, to Medtronic as indicated in the enclosed Customer Confirmation Form. Please complete the enclosed Customer Confirmation Form, even if you have no product to return. Pas |
| Quantity | 1681 units |
| Distribution | Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173270 | Tri-Staple 2.0 Reinforced Reload Covidien, Feb 20, 2018 |