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.
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. Distribution: Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan. Quantity: 3,023 units Lot/code info: Model Number: SIGSDS30CTVT; UDI/DI: 10884521741888; Lot numbers: N3L1909UY, N3L1868UY, N3L2008UY, N3L2221UY, N3M1541UY, N3M1603UY, N3M1639UY;
10884521741888
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.