Notable recalls include the Class 2 Device Recall for USTAR II Knee System’s Cemented Curved Stem and PressFit Curved Stem due to potential incorrect orientation. Additionally, the Triathlon Total Knee System faces recall for potential packaging breaches. The Exactech Equinoxe Shoulder System is also under scrutiny for defective packaging, which lacked crucial oxygen barrier layers, risking oxidation and degradation of plastic components. For more details, visit the FDA’s website or contact Industry 411.
Sources:
Class 2 Device Recall USTAR II Knee System: Cemented Curved Stem, RHS Ti Plasma Spray
Class 2 Device Recall USTAR II Knee System PressFit Curved Stem, RHS Ti Plasma Spray
Class 2 Device Recall Triathlon Total Knee System
Risks with Exactech Equinoxe Shoulder System with Defective Packaging
