Official recall notice

FDA DeviceClass IINotable

FDA Recall: Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Hume

Recall date
2026-04-01
FDA class
Class II

Why it was recalled

Hazard

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Recommended action

What to do

292 units

Product description

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Verify with the official notice →
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