I.T.S. GmbH recalled 220 Volar Radius Plate PROlock II devices after updated MRI safety testing showed higher RF-induced temperatures under certain MRI conditions. The devices were distributed nationwide in the United States. Clinicians and patients should stop using the device immediately and follow the manufacturer recall instructions.
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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Product: Volar Radius Plate with Angular Stability, 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 and related lot numbers Quantity: 220 units Distribution: US Nationwide (AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W) Sold At: Multiple Retailers Recall Date: 2026-01-23 Status: Active Hazard: Higher RF-induced temperature increases during MRI under certain conditions beyond what is described in the IFU Remedy: Stop using the device and follow
MRI sessions with affected plates may experience greater heating. The condition could increase tissue or device surface temperature during scanning, potentially causing injury.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions issued by I.T.S. GmbH. 3. Contact I.T.S. GmbH or your healthcare provider for further instructions. 4. Do not resume MRI scanning with the device until cleared by a clinician. 5. Monitor for recall notices from the manufacturer and exchange or remove per their guidance.
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