I.T.S. recalls specific orthopedic plates (DFL and PTL models) due to MRI safety risks. Updated testing shows these implants can cause higher temperature increases during MRI scans than previously stated, potentially leading to burns.
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. is recalling certain orthopedic plates used in bone repairs because MRI safety testing shows they can cause higher temperature increases during scans than previously reported. This could lead to burns in patients undergoing MRI procedures.
The plates can generate higher temperatures when exposed to MRI machine magnetic fields than previously documented. This temperature increase could cause burns on the skin or underlying tissues during an MRI scan if the patient is not properly monitored.
Patients with the recalled orthopedic plates who undergo MRI scans are at risk. Medical professionals using these plates in surgeries may also need to take extra precautions during imaging procedures.
Check if your orthopedic plate has article numbers listed: 21301-5 through 21325-7. The plates are sold with specific lot numbers that include the '26/F' prefix followed by a number.
Review the article numbers and lot numbers on your orthopedic plate to confirm if it is in the recalled list.
Reach out to I.T.S. GmbH directly for guidance on next steps if you have the recalled plates.
Updated MRI safety testing shows these plates can cause higher temperature increases during scans than previously stated in the product instructions, which could lead to burns.
No, the recall does not require immediate discontinuation. Patients should inform their healthcare provider about the recall before any MRI scans.
Check for article numbers 21301-5 through 21325-7 with specific lot numbers starting with '26/F' followed by a number.
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-1603-2026 — I.T.S. I.T.S. Hello, I own a I.T.S. that is covered by recall Z-1603-2026 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.
