Stabiliz OrthopaedicsDecember 9, 2024

FDA 483 - Stabiliz Orthopaedics - December 09, 2024

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Stabiliz Orthopaedics

Record Details

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.

Company: Stabiliz Orthopaedics
Inspection Date: December 9, 2024
Product Type: Device
Office: Philadelphia District Office
Person: Nadia R. Barreda

Open in Dashboard

ID · 337bfbe3-5b84-42e8-b9ad-6c565549ecbc