I.T.S. GmbH Humeral Head Plate Recall Due to MRI Safety Risk
Summary
FDA issued Class II recall for I.T.S. GmbH Humeral Head Plates after updated MRI safety testing revealed higher RF-induced temperature increases under certain MRI conditions than previously disclosed in Instructions for Use. The affected products include proximal humeral plates with multiple article numbers distributed nationwide. Healthcare providers must identify patients with implanted devices and implement appropriate MRI protocols.
What changed
FDA classified a Class II recall for I.T.S. GmbH Humeral Head Plates with Angular Stability after post-market MRI safety testing demonstrated higher RF-induced heating than previously reflected in product labeling. The recall affects multiple article numbers including 211341-10, 211341-4, 211341-7, and others. Distribution included hospitals and surgical centers in multiple states.
Healthcare providers who have performed surgeries with these implants must inform affected patients of the updated MRI safety information. Radiologists and MRI technicians should review contraindication protocols before scanning patients with these devices. Manufacturers of similar orthopedic implants should review their MRI safety data and labeling to ensure accuracy.
What to do next
- Identify any inventory of affected Humeral Head Plate article numbers
- Notify surgeons and radiologists about MRI safety concerns for patients with implanted devices
- Review and update MRI protocols for patients with these plates
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-1594-2026 · 20260401 · Ongoing
Product
Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 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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