Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Reported: April 10, 2024 Initiated: February 14, 2024 #Z-1457-2024
Product Description
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
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.
Details
- Recalling Firm
- Covidien, LP
- Units Affected
- 30 Units
- Distribution
- Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT. Recalled by Covidien, LP. Units affected: 30 Units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1457-2024.
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