# FDA 483 - Stryker Medical Division of Stryker Corporation - November 15, 2024

Source: https://www.globalkeysolutions.net/records/483/stryker-medical-division-of-stryker-corporation/b81c2c8a-3d51-48d5-8f89-3947ca79ef90

> FDA 483 for Stryker Medical Division of Stryker Corporation on November 15, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stryker Medical Division of Stryker Corporation
- Inspection Date: 2024-11-15
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of Stryker Medical Division of Stryker Corporation in Portage, MI, revealed two significant observations regarding their quality system. The firm failed to adequately establish design verification procedures, specifically concerning worst-case product configuration, and did not adequately validate a critical manufacturing process parameter for the Power Pro 2 device.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.globalkeysolutions.net/companies/stryker-medical-division-of-stryker-corporation/8540f6c7-6bb7-4c61-a1e6-cefe0fd53937

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03