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Medium risk Medical DevicesClass II

I.T.S. Foot Locking Plates & Hallux Osteotomy Recall

FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1.

Updated January 23, 2026

The FLS Foot Locking Plates System and HOL Hallux Osteotomy Locking Plate may heat up more than expected during an MRI scan. Updated safety testing found higher temperature increases under certain MRI conditions than the manufacturer previously disclosed.

Is the I.T.S. GmbH recalled? Yes. This product was recalled by FDA on January 23, 2026. Details below.

What is recalled

FLS Foot Locking Plates System and HOL Hallux Osteotomy Locking Plate by I.T.S. GmbH, including: FLS Cancellous Stabilization Screws (37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30); FLS Cortical Screws (32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34); FLS Cortical Stabilization Screws (37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24); FLS Curved Plate (21413-6); FLS H-Shape Plate (21431-ME); FLS L-Shape Plates (21482, 21483); FLS Straight Plate (21421-5); FLS Stabilization Screws (37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30); HOL Hallux Osteotomy Plates (21015-08, 21015-09).

Am I affected

You're affected if you have a foot or toe implant from I.T.S. GmbH and the article number on your implant or medical records matches any listed above, particularly if you have had or plan to have an MRI scan.

What to do right now

If you have one of these implants, inform your doctor or MRI facility of the article number before any MRI scan. Your healthcare provider can advise whether an MRI is safe for you or what precautions to take. Contact your healthcare provider or the hospital where your implant was placed if you have questions.

The hazard

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Brands affected

I.T.S. GmbH
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1605-2026
Classification
Class II
Recalled
January 23, 2026
Read the official notice

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