Acrobat-i Stabilizer Z and Acrobat-i Positioner Z

The contract manufacturer of the Acrobat product family reported deviations in the manufacturing process that creates the sterile barrier. Specifically, in some instances, the tray sealing step was  performed multiple times using the same package, which is outside of the validated process. Although testing suggests that product is sterile immediately after being sealed with this non-validated process, we cannot ensure that the product will remain sterile for the duration of its 2-year shelf life.

Recall Start Date: October 21, 2024