I.T.S. recalls certain Fibula Plate PROlock models due to potential MRI safety risks. Updated MRI testing shows higher RF 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. is recalling specific models of Fibula Plate PROlock with Angular Stability implants. These devices may cause higher temperature increases during MRI scans than previously reported, potentially leading to tissue damage.
MRI scans use strong magnetic fields that can interact with metal implants. These plates may heat up more than expected during MRI, potentially causing burns or tissue damage if not properly accounted for in the scan protocol.
People who have the specific model numbers listed in the recall notice, particularly those who may undergo MRI scans. Patients with these implants are at risk during MRI procedures.
Check your implant's article numbers: 21602-3 through 21603-8 for the Fibula Plate PROlock models. Also look for specific lot numbers listed in the recall notice.
Identify your implant's article number and lot numbers from the list provided in the recall notice.
Talk to your healthcare provider about MRI safety if you have this implant and plan to undergo scans.
Updated MRI safety testing shows these implants may cause higher temperature increases during scans than previously stated in the instructions.
No, but you should discuss MRI safety with your doctor if you plan to have scans.
Check your implant's article numbers (21602-3 through 21603-8) and lot numbers as listed in the recall notice.
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-1601-2026 — I.T.S. I.T.S. Hello, I own a I.T.S. that is covered by recall Z-1601-2026 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.
