Stryker has identified a nonconformance relating to the Evolve Triad Plate Cutter provided in the Evolve Triad Instrument Kit (4951kit1). Specifically, the plate cutter is unable to meet sterilization requirements when it is sterilized in a double wrapped configuration according to the option 1 steam sterilization parameters detailed in Instructions for Use (IFU150824). While the surgical technique does not require use of the plate cutter, it is provided in the instrument kit so the coronoid plate can be trimmed when needed. Recall start date: June 3, 2022
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