I.T.S. GmbH recalls Volar Radius Plate PROlock II due to potential MRI safety risks from RF-induced temperature increases. Affected models include specific article numbers and lot numbers.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbH is recalling their Volar Radius Plate PROlock II for potential MRI safety risks. The device may cause higher temperature increases during MRI scans than previously stated, which could lead to burns or other injuries.
MRI scans use strong magnetic fields that can cause the device to heat up. The recall shows that the device may cause higher temperature increases than previously reported, potentially leading to burns or tissue damage during MRI procedures.
Orthopedic patients using the Volar Radius Plate PROlock II for hand surgery are most at risk. Patients who have this device and plan to undergo MRI scans should be cautious.
Check for the product name 'Volar Radius Plate with Angular Stability' and the specific article numbers listed in the recall notice. The device has a PROlock II description and includes the listed model numbers and lot numbers.
Look for the product name 'Volar Radius Plate with Angular Stability' and the specific article numbers listed in the recall notice.
Reach out to I.T.S. GmbH for further assistance or to confirm if your device is affected.
Updated MRI safety testing shows the device may cause higher temperature increases during MRI scans than previously stated, potentially leading to burns or tissue damage.
The affected models include specific article numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, and 21036-3.
No, but patients planning MRI scans should be cautious as the device may cause temperature increases during scans.
We’ve drafted a message you can send I.T.S. GmbH to request your refund or repair — edit it as you like.
Subject: Recall Z-1592-2026 — I.T.S. GmbH I.T.S. GmbH Hello, I own a I.T.S. GmbH that is covered by recall Z-1592-2026 from I.T.S. GmbH. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
