I.T.S. GmbH recalls Claviculaplate with Angular Stability due to potential MRI safety risks from RF-induced temperature increases. Affected models include specific article numbers and lot ranges.
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 Claviculaplate with Angular Stability models because MRI safety testing shows they could cause higher temperature increases during MRI scans than previously stated. This could lead to burns or other injuries if used improperly in MRI settings.
MRI machines use strong magnetic fields and radio waves. These plates can heat up more than expected during MRI scans, potentially causing burns or tissue damage if the temperature rises too high.
Patients using these plates for clavicle fractures who undergo MRI scans are most at risk. The recall affects specific models sold with certain article numbers and lot ranges.
Check the product label for article numbers: 21116-8, 21117-10, 21118-10, 21121-6, 21121-8, 21122-10, 21122-6, 21122-8, 21123-4, 21124-4, 21127-6, or 21128-6. Also check the lot numbers listed in the recall notice.
Look for article numbers and lot numbers listed in the recall notice to confirm if your plate is affected.
MRI safety testing shows these plates could cause higher temperature increases during scans than previously stated, potentially leading to burns.
Check the product label for article numbers and lot numbers to see if it's affected. If it is, contact I.T.S. GmbH for instructions.
Yes, if used in MRI scans, the plate could heat up and cause burns or tissue damage.
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-1593-2026 — I.T.S. GmbH I.T.S. GmbH Hello, I own a I.T.S. GmbH that is covered by recall Z-1593-2026 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.
