I.T.S. Straight Plate with Angular Stability models may cause unsafe temperature increases during MRI scans. Affected units include specific forearm and straight plates with listed 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. recalls certain straight plates with angular stability due to MRI safety risks. These devices may cause higher temperature increases during MRI scans than previously stated, potentially leading to burns.
Updated MRI safety testing shows these plates can cause higher temperature increases in the body during MRI scans than previously reported. This risk could lead to burns if the device is used in MRI environments without proper safety checks.
Users of I.T.S. Straight Plate with Angular Stability products, particularly those who undergo MRI scans. Individuals with the specific model numbers and lot numbers listed in the recall are most at risk.
Check for the specific product models: Forearm Plate, Curved; Forearm Plate, Straight; Straight Compression Plate; or Straight Plates (1.5mm, 2.0mm, 3.5mm, 4.5mm). Look for the listed article numbers and corresponding lot numbers in the recall details.
Identify your product model and article numbers to confirm if it's affected by this recall.
Reach out to I.T.S. GmbH for guidance on next steps if your product is affected.
Updated MRI safety testing shows these plates can cause higher temperature increases during MRI scans than previously stated, potentially leading to burns.
Affected models include Forearm Plate, Curved (article numbers 21604-6, 21604-9); Forearm Plate, Straight (article numbers 21605-11, 21605-6, 21605-9); Straight Compression Plate (article numbers 21105-6, 21105-8); and Straight Plates (1.5mm, 2.0mm, 3.5mm, 4.5mm) with specific article numbers listed in the recall.
No, but if you use this product in an MRI environment, you should contact I.T.S. GmbH for guidance as the product may cause unsafe temperature increases.
We’ve drafted a message you can send I.T.S. to request your refund or repair — edit it as you like.
Subject: Recall Z-1598-2026 — I.T.S. I.T.S. Hello, I own a I.T.S. that is covered by recall Z-1598-2026 from I.T.S.. 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.
