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
This recall is currently active, issued May 24, 2024.
- Recall Initiated
- April 15, 2024
- Posted
- May 24, 2024
- Recall Number
- Z-1891-2024
- Quantity
- 1681 units
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
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.
Lot / Code Info
GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
Root Cause
Under Investigation by firm
Action Taken
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. Pass on this information to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please keep a copy of this letter in your file. If you have any questions regarding this communication, please contact your Medtronic Representative Customer Service at 800-962-9888, option 2.