Stryker Ireland, Ltd., Instruments Division – FDA 483, Jul 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.
ID · 7851a072-3dd8-4289-a565-67c6e6908826
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