device recall
saveI.T.S. GmbH device recall (Cls II)
January 23, 2026updated 3mo ago
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Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3. — Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). — Status: Ongoing
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