ITS GmbH Foot Plate Systems MRI Safety Class II Recall
Summary
FDA initiated Class II recall Z-1605-2026 for I.T.S. GmbH Foot Locking Plates System (FLS) and Hallux Osteotomy Locking Plate (HOL) due to updated MRI safety testing showing higher RF-induced temperature increases under certain MRI conditions than previously stated in Instructions for Use. Affected products distributed nationwide to healthcare facilities in multiple states. Recall is ongoing.
What changed
FDA classified a Class II recall for I.T.S. GmbH Foot Locking Plates System (FLS) and Hallux Osteotomy Locking Plate (HOL) devices. Updated MRI safety testing revealed higher RF-induced temperature increases than previously documented in Instructions for Use. The recall affects products distributed nationwide across multiple states.
Healthcare facilities using these foot plate systems must immediately identify affected inventory, update MRI safety protocols, and ensure all relevant clinical staff are aware of the revised MRI heating risk. Adverse events potentially related to this issue should be reported to FDA through MedWatch. The recall remains ongoing with no specified termination date.
What to do next
- Identify all affected I.T.S. GmbH FLS and HOL foot plate inventory in your facility
- Update MRI safety protocols and IFU references for affected devices
- Notify orthopedic and surgical staff about MRI heating risk and monitor for adverse events
Archived snapshot
Apr 9, 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-1605-2026 · 20260401 · Ongoing
Product
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabiliz...
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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Source document text, dates, docket IDs, and authority are extracted directly from ITS.
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