I.T.S. GmbH recalls certain Distal Humeral Plates with Angular Stability due to potential MRI heating risks. Updated MRI safety testing shows higher RF-induced 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. GmbH is recalling specific Distal Humeral Plates with Angular Stability that may cause overheating during MRI scans. This could lead to burns or tissue damage if used with MRI machines.
These plates may generate excessive heat during MRI scans due to radiofrequency (RF) energy. Updated testing shows higher temperature increases than previously stated in the product instructions, which could cause burns or tissue damage.
Patients who have received these specific Distal Humeral Plates with Angular Stability for orthopedic surgery are affected. Those undergoing MRI scans after implantation are at highest risk.
Check for the following article numbers: 37351-10-N to 37351-85-N for Cortical Screw, Locking plates; 21241-5 to 21244-9 for Humeral Plate, Distal models. Lot numbers are listed in the recall notice.
Identify your plate's article numbers and lot numbers as listed in the recall notice to confirm if it's affected.
Reach out to I.T.S. GmbH directly for guidance on next steps if you have the recalled product.
Updated MRI safety testing shows these plates may cause higher RF-induced temperature increases than previously stated in the Instructions for Use, potentially leading to burns during MRI scans.
Check for article numbers 37351-10-N to 37351-85-N for Cortical Screw, Locking plates or 21241-5 to 21244-9 for Humeral Plate, Distal models, along with the specific lot numbers listed in the recall notice.
Contact I.T.S. GmbH directly to get guidance on next steps; the recall does not include a specific remedy like replacement or repair.
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-1602-2026 — I.T.S. GmbH I.T.S. GmbH Hello, I own a I.T.S. GmbH that is covered by recall Z-1602-2026 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.
