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

Source: https://www.globalkeysolutions.net/records/483/stryker-ireland-ltd-instruments-division/7851a072-3dd8-4289-a565-67c6e6908826

> FDA 483 for Stryker Ireland, Ltd., Instruments Division on July 25, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stryker Ireland, Ltd., Instruments Division
- Inspection Date: 2024-07-25
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Sara M. Onyango](https://www.globalkeysolutions.net/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.globalkeysolutions.net/companies/stryker-ireland-ltd-instruments-division/96bc37c8-ed9f-42ff-830a-20ed843c01be

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd