I.T.S. GmbH recalled 322 Claviculaplate with Angular Stability devices sold nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than the IFU reflected. Healthcare providers and patients should stop using the device immediately and follow recall instructions from the manufacturer.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact I.T.S. GmbH or your healthcare provider for instructions. Notification method: E-Mail
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Brand: I.T.S. GmbH. Product: Claviculaplate with Angular Stability. Article numbers: 21116-8, 21117-10, 21118-10; 21121-6, 21121-8; 21122-10, 21122-6, 21122-8; 21123-4, 21124-4, 21127-6, 21128-6. Sold nationwide in the United States. Quantity: 322 units. Recall date: 2026-01-23. Status: ACTIVE.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use.
No injuries or incidents have been reported.
1. Stop using the product. 2. Contact I.T.S. GmbH or your healthcare provider for instructions. 3. Follow the recall instructions provided by the manufacturer. 4. If you need a replacement or refund, contact I.T.S. GmbH by email as noted in the recall notification.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1593-2026. Manufacturer: I.T.S. GmbH. Notification method: Email.
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