FDA 483 - Stryker Ireland, Ltd., Instruments Division - July 25, 2024

Stryker Ireland, Ltd., Instruments Division in Carrigtwohill, Ireland, was cited for inadequate control of non-conforming products during an FDA inspection. The firm failed to complete a field action assessment for a smoke evacuation pencil with numerous complaints of unintended activation and associated burns. Additionally, distributed units of a dental bur exceeded quality specifications, and the firm's risk assessment for these units was found to be inadequate given their potential use on bone.