Signia" Small Diameter Curved Tip Intelligent Reload recall
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Why was Signia" Small Diameter Curved Tip Intelligent Reload recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: SIGSDS30CTVT; UDI/DI: 10884521741881; Lot number: N3L1909UY;
- Product
- Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
- Recalling firm
- Covidien, LP
- Quantity
- 30 Units
- Distribution
- Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
- Recall date
- April 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)