| Class 2 Device Recall TriStaple" 2.0 Black Reinforced Intelligent Reload | |
Date Initiated by Firm | April 15, 2024 |
Date Posted | May 24, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1891-2024 |
Recall Event ID |
94484 |
510(K)Number | K173270 |
Product Classification |
Staple, implantable - Product Code GDW
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Product | 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 |
Code Information |
GTIN: 10884521717633
20884521717630
Lot #: N3G1372Y |
Recalling Firm/ Manufacturer |
Covidien, LP 60 Middletown Ave North Haven CT 06473-3908
|
For Additional Information Contact | Kati Salefski 508-452-4894 |
Manufacturer 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 |
FDA Determined Cause 2 | 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.
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. |
Quantity in Commerce | 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.
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Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = GDW
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