Recall of I.T.S. Hand Locking Plates System components due to potential MRI safety risks from RF-induced temperature increases. Affected items include specific cortical screws and plates with listed article 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 hand locking plates system components because updated MRI safety testing shows these items could cause higher temperature increases during MRI scans than previously stated. This could pose a risk of injury if used in MRI environments.
The recalled components can cause higher RF-induced temperature increases during MRI scans than previously indicated in the product instructions. This risk occurs because the materials may heat up excessively when exposed to MRI machine radiation, potentially causing burns or other injuries.
Users of the I.T.S. Hand Locking Plates System components with the listed article numbers are affected. Patients undergoing MRI scans with these items may be at risk of injury due to temperature increases.
Check if your I.T.S. Hand Locking Plates System includes any of the listed article numbers: 32151-6 through 32151-20 for cortical screws, 21505-4 through 21514-5 for plates, or 37151-5 through 37251-20 for locking screws.
Identify your specific article numbers from the list provided in the recall notice to confirm if your product is affected.
Reach out to I.T.S. GmbH directly for assistance with the recall process or to confirm if your product is affected.
Updated MRI safety testing shows these components could cause higher temperature increases during MRI scans than previously stated in the product instructions.
The affected items include cortical screws with article numbers 32151-6 through 32151-20, plates with article numbers 21505-4 through 21514-5, and locking screws with article numbers 37151-5 through 37251-20.
No, the recall does not require immediate discontinuation. However, if you use these products in MRI environments, you should contact I.T.S. GmbH for guidance.
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-1607-2026 — I.T.S. GmbH I.T.S. GmbH Hello, I own a I.T.S. GmbH that is covered by recall Z-1607-2026 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.
