| Date Initiated by Firm |
February 14, 2024 |
| Date Posted |
April 01, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1457-2024 |
| Recall Event ID |
94128 |
| 510(K)Number |
K191070
|
| Product Classification |
Staple, implantable - Product Code GDW
|
| Product |
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT |
| Code Information |
Model Number: SIGSDS30CTVT; UDI/DI: 10884521741881; Lot number: N3L1909UY; |
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 |
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
On February 14, 2024, the firm notified domestic customers and notified international customers starting February 19, 2024 of the issue via URGENT: MEDICAL DEVICE RECALL letters. Actions to be taken by the customer: 1. Identify and quarantine all unused impacted product listed above. 2. See Attachment A for guidance on identifying affected lots. 3. Return all quarantined devices to Medtronic. Please contact rs.covidienfeedbackcustomerservice@medtronic.com for the Return Goods Authorization (RGA). 4. Credit for the returned affected devices will be issued based on the RGA number. 5. If purchased from a distributor, contact your distributor directly to arrange for the return of the devices back to your distributor. 6. Please complete and return the enclosed Customer Confirmation Form to rs.gmbmitgfca@medtronic.com even if you do not have unused inventory. 7. Pass on this notice to all those who need to be aware within your organization or to any organization where the listed affected lots may have been transferred or distributed. Adverse events or quality problems experienced with this product should be reported to the FDA and Medtronic: Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, or call FDA at 1-800-FDA-1088 (1-800-332-1088) and Medtronic Technical Services at 800-255-6774, option 2 to provide information regarding those events. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Field Representative or Customer Service at 800-962-9888 Option 2. |
| Quantity in Commerce |
30 Units |
| Distribution |
Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan. |
| Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = GDW and Original Applicant = Covidien
|
