483
Stabiliz OrthopaedicsStabiliz Orthopaedics – FDA 483, Dec 9, 2024
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.
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