ITS GmbH Class II Recall: MRI Safety Temperature Risk in LRS Distal Femur Plates
Summary
FDA initiated Class II recall Z-1603-2026 for I.T.S. GmbH LRS (Locking Reconstruction System) Distal Femur Locking Plates after updated MRI safety testing revealed higher RF-induced temperature increases under certain MRI conditions than previously documented in the Instructions for Use. The affected article numbers include 21301-5, 21301-7, and additional products distributed nationwide. Healthcare providers and distributors must immediately review inventory, identify affected devices, and update MRI protocols for patients with these implants.
What changed
FDA Class II recall Z-1603-2026 affects I.T.S. GmbH LRS (Locking Reconstruction System) Distal Femur Locking Plates. Updated MRI safety testing under certain conditions demonstrated higher RF-induced temperature increases than previously reflected in the Instructions for Use. This recall is ongoing with US nationwide distribution.
Healthcare providers using these orthopedic implants must review patient records to identify those who have received the affected devices, update pre-MRI screening procedures to account for elevated RF heating risks, and communicate updated safety information to patients. Distributors and medical facilities should quarantine any remaining inventory and coordinate with I.T.S. GmbH for further guidance on the revised MRI safety parameters.
What to do next
- Immediately audit inventory for affected I.T.S. LRS Distal Femur Plate article numbers (21301-5, 21301-7, and associated products)
- Update MRI safety protocols and patient counseling materials to reflect revised temperature increase data
- Report any adverse events related to MRI procedures with affected devices to FDA MedWatch
Penalties
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Archived snapshot
Apr 10, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
I.T.S. GmbH
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1603-2026 · 20260401 · Ongoing
Product
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21...
Reason for Recall
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Distribution
US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA...
Source: openFDA Enforcement API
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