I.T.S. GmbH recalls Olecranonplate with Angular Stability 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 certain Olecranonplate with Angular Stability models because MRI safety testing shows higher risk of temperature increases during MRI scans than previously stated. This could lead to burns or other injuries if the device is used in MRI environments.
The device may cause higher temperature increases in MRI environments than previously reported, potentially leading to burns or tissue damage. This risk occurs when the device is placed near MRI machines during scans.
Patients using the recalled Olecranonplate with Angular Stability for medical treatments are most at risk if they undergo MRI scans. Healthcare providers who use these plates should also check for affected models.
Check for the specific article numbers: 21112-7, 21114-5, 21113-9 for the hook plate, and 21111-6, 21111-8, 21111-12 for the plate. Also verify the lot numbers listed in the recall notice.
Review the article numbers and lot numbers listed in the recall notice to confirm if your device is affected.
The recall indicates potential MRI safety risks, but the device may be safe if used properly outside MRI environments. Affected models require specific safety checks.
Check the article numbers and lot numbers listed in the recall notice to determine if your device is affected. If it is, contact I.T.S. GmbH for further instructions.
Yes, but if you plan to use it in MRI environments, you should avoid it due to the potential risk of temperature increases.
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-1597-2026 — I.T.S. GmbH I.T.S. GmbH Hello, I own a I.T.S. GmbH that is covered by recall Z-1597-2026 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.
