FDA 483 - Stabiliz Orthopaedics - December 09, 2024

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.