FDA Enforcement
Class II
Ongoing
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Recall: Z-1457-2024
·
Reported April 10, 2024
Enforcement
- Recall Number
- Z-1457-2024
- Event ID
- 94128
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 10, 2024
- Initiation Date
- February 14, 2024
- Classification Date
- April 1, 2024
- Address
- 60 Middletown Ave, North Haven, CT, 06473-3908, United States
Description
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Reason
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.
Code Info
Model Number: SIGSDS30CTVT; UDI/DI: 10884521741881; Lot number: N3L1909UY;
Distribution
Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
Quantity
30 Units