I.T.S. GmbH recalls specific Pilonplate models due to potential MRI safety risks from RF-induced temperature increases. Affected units include certain anterolateral tibia plates and pilon plates with specific 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 specific Pilonplate models with Angular Stability because MRI safety testing shows higher risk of temperature increases during MRI scans than previously stated. This could lead to burns or other injuries if the device is used in MRI environments without proper safety checks.
The Pilonplate models can cause higher RF-induced temperature increases during MRI scans than previously reported. This risk occurs because the device's magnetic properties interact with MRI equipment, potentially leading to burns or other injuries if not properly managed.
Orthopedic surgeons and medical professionals who use these plates in MRI-compatible procedures are most at risk. Patients with these implants may face safety issues during MRI scans if not properly checked.
Check for specific article numbers listed: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7 for anterolateral tibia plates; 21094-10, 21094-4, 21094-6, 21094-8 for 4mm pilon plates; and 21093-4, 21093-6 for small pilon plates.
Identify the article numbers on your Pilonplate to confirm if it is affected by this recall.
Reach out to I.T.S. GmbH for guidance on MRI safety procedures if you have the affected product.
MRI safety testing shows higher RF-induced temperature increases than previously stated in the product instructions, which could cause burns during MRI scans.
Affected models include anterolateral tibia plates (article numbers 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7) and pilon plates (article numbers 21094-10, 21094-4, 21094-6, 21094-8, 21093-4, 21093-6).
No, but you should check if your product is affected and consult with I.T.S. GmbH for MRI safety procedures if needed.
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-1596-2026 — I.T.S. GmbH I.T.S. GmbH Hello, I own a I.T.S. GmbH that is covered by recall Z-1596-2026 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.
