I.T.S. recalls headless compression screws with higher MRI temperature risks. Updated MRI testing shows potential for RF-induced heating during scans. Affected models include specific 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. is recalling headless compression screws that may cause overheating during MRI scans due to higher RF-induced temperature increases than previously stated. This could lead to burns or other injuries if used in MRI settings without proper safety checks.
The screws can heat up during MRI scans due to radiofrequency energy, potentially causing burns or tissue damage. This risk was not fully accounted for in the original safety instructions.
Patients using these screws for spinal or joint repairs who undergo MRI scans are at risk. Medical professionals who use the screws in procedures involving MRI equipment should also be cautious.
Check for article numbers like 31207-10 through 31757-90 on the packaging or label. Lot numbers are listed in the recall notice for specific batches.
If you have these screws and plan to undergo an MRI scan, contact your doctor or MRI facility immediately to discuss alternatives.
No, but if you have an MRI scan planned, you should consult your doctor or facility about alternatives.
Article numbers 31207-10 through 31757-90, with specific lot numbers listed in the recall notice.
The recall does not provide a fix; users must avoid MRI scans with these screws or consult their healthcare provider.
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-1606-2026 — I.T.S. I.T.S. Hello, I own a I.T.S. that is covered by recall Z-1606-2026 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.
