I.T.S. GmbH Distal Humeral Plates Class II MRI Safety Recall
Summary
FDA announced a Class II recall of I.T.S. GmbH Distal Humeral Plates with Angular Stability after updated MRI safety testing revealed higher RF-induced temperature increases under certain MRI conditions than previously disclosed in Instructions for Use. The recall affects multiple plate sizes and associated cortical and locking screws with article numbers 37351-xx-N and related series. Distribution spans US states including AL, AZ, CA, CO, FL, GA, IL, and 30+ additional states.
What changed
I.T.S. GmbH initiated a Class II recall for Distal Humeral Plates with Angular Stability after discovering that updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use. The affected products include Distal Humeral Plates along with Cortical Screws (locking and non-locking) and related surgical components with specific article numbers.
Healthcare providers, hospitals, and surgical centers using these devices must immediately identify patients who have received these implants and update their MRI safety protocols. Facilities should review all inventory against the affected article numbers and communicate the updated safety information to relevant radiology and surgical staff. The recall has nationwide US distribution across more than 30 states.
What to do next
- Identify all affected Distal Humeral Plates and associated screws in inventory using article numbers
- Notify all surgeons and healthcare facilities using these devices about updated MRI safety information
- Update patient records and MRI protocols to reflect new RF-induced heating risk data
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-1602-2026 · 20260401 · Ongoing
Product
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 3735...
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
Named provisions
Related changes
Get daily alerts for FDA: Device Recalls Class II
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from FDA.
The plain-English summary, classification, and "what to do next" steps are AI-generated from the original text. Cite the source document, not the AI analysis.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when FDA: Device Recalls Class II publishes new changes.