HIGHFDA DEVICE
ITS Fibula Plate PROlock with Angular Stability Recall Affects 869 Units (2026)
ITS recalls 869 Fibula Plate PROlock with Angular Stability implants distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than previously reflected in the IFU. Hospitals and healthcare providers should stop using this device immediately and follow the recall instructions.
ITS
Updated MRI