FDA Warns Surgeons Not to Use Synovo Total Hip Resurfacing System
January 3, 2024
WASHINGTON, D.C. — The Food and Drug Administration has recommended that surgeons stop implanting Synovo Production Inc.’s Total Hip System because three of the components “have been significantly modified” from the devices cleared by the agency.
In a Jan. 3 Safety Communication, the FDA explained that the safety and effectiveness of the system and its components have not been established. The components that were modified were the femoral resurfacing cup, acetabular fixation cup and acetabular bearing.
The Synovo Total Hip System may use the Acetabular Fixation Cup and/or the Acetabular Bearing along with a conventional femoral stem and head component. …