Stryker has become aware of recently published data and post market reports indicating that patients implanted with Cartiva SCI may experience a higher-than- expected occurrence rate when compared to data submitted in the 2016 PMA of the following documented hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation. Cartiva SCI devices have been observed in some cases to be revised/removed at higher rates than previously observed in the initial Cartiva SCI premarket and post-approval studies. Recall start date: October 31, 2024
RecallTracker