I.T.S. GmbH recalls FR.O.H. Calc: Anterolateral Calcaneus Plate (Article 21064-60) due to potential MRI temperature increases. Affected units sold with specific 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. GmbH is recalling their FR.O.H. Calcaneus Repair System (Anterolateral Calcaneus Plate) because MRI safety testing shows it could cause higher temperature increases during scans than previously stated. This risk could lead to burns or other injuries if used with MRI machines.
The repair system may cause higher temperature increases in MRI machines than previously reported. This could lead to burns or tissue damage during scans if the device is present in the body.
Orthopedic surgeons and medical professionals who use this specific plate in surgeries. Patients undergoing MRI scans with this implant are at risk of burns.
Check for the article number 21064-60 on the plate. Affected units include lot numbers 679/012318 and 679/0722100.
Look for the article number 21064-60 and lot numbers 679/012318 or 679/0722100 on the plate.
The recall indicates potential temperature increases during MRI scans, so it is not safe for MRI use without further evaluation.
The recall does not specify a remedy, so check with the manufacturer for guidance.
Look for the article number 21064-60 and lot numbers 679/012318 or 679/0722100 on the plate.
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-1595-2026 — I.T.S. GmbH I.T.S. GmbH Hello, I own a I.T.S. GmbH that is covered by recall Z-1595-2026 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.
