Official recall notice
FDA DeviceClass IINotable
FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-8030/12;
- Recall date
- 2026-03-18
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Recommended action
What to do
4 units (all OUS)
Product description
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.