I.T.S. GmbH recalls specific screw and washer models due to updated MRI safety testing showing higher RF-induced temperature increases than previously stated in instructions.
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 screw and washer products used in medical implants because MRI safety testing shows these items could cause higher temperature increases in the body during MRI scans than previously reported. This risk could potentially lead to tissue damage if the items are used in MRI procedures without proper safety checks.
Updated MRI safety testing found that the recalled screws and washers can cause higher temperature increases in the body during MRI scans than previously stated in the product instructions. This risk occurs due to radiofrequency energy interactions that may lead to tissue damage if the items are used improperly in MRI environments.
Medical professionals and patients who use the recalled I.T.S. screw and washer products in MRI procedures are most at risk. The specific models and lot numbers are listed in the recall notice.
Check your I.T.S. screw and washer products for the specific article numbers and lot numbers listed in the recall notice. The products include cancellous screws, cortical screws, washers, and specific model numbers with corresponding lot numbers.
Identify your product by checking the article numbers and lot numbers listed in the recall notice.
Reach out to I.T.S. GmbH for guidance on whether your specific product is affected and what steps to take.
Updated MRI safety testing shows these products could cause higher temperature increases in the body during MRI scans than previously stated in the instructions.
The affected products include specific cancellous screws, cortical screws, washers, and their corresponding article numbers and lot numbers listed in the recall notice.
No, but you should check if your product is affected and contact I.T.S. GmbH for guidance before using them in MRI procedures.
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-1599-2026 — I.T.S. I.T.S. Hello, I own a I.T.S. that is covered by recall Z-1599-2026 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.
