There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
Reason for recall: There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together. Distribution: Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden. Quantity: 1 units Lot/code info: UDI-DI: 10884521784062; Serial Numbers: C21RXG0005
10884521784062
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.