# FDA 483 - Stabiliz Orthopaedics - December 09, 2024

Source: https://www.keypedia.com/records/483/stabiliz-orthopaedics/337bfbe3-5b84-42e8-b9ad-6c565549ecbc

> FDA 483 for Stabiliz Orthopaedics on December 09, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stabiliz Orthopaedics
- Inspection Date: 2024-12-09
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: Stabiliz Orthopaedics in Exton, PA, was cited for significant deficiencies in its design control process for its Class II hip screw-fixation orthopedic implant. The inspection revealed inadequate design plans, vague design inputs, incomplete traceability matrices, and a failure to implement design change procedures for multiple product modifications. These issues raise concerns about the safety and effectiveness of distributed products.

## Related Officers

- [Nadia R. Barreda](https://www.keypedia.com/people/nadia-r-barreda/ef624359-957a-45e4-89c9-5b5ff215c6aa)

Company: https://www.keypedia.com/companies/stabiliz-orthopaedics/2c6a8d7c-9966-4a42-a0d9-0a81d8b6076d

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8