I.T.S. GmbH Olecranonplate, Class II MRI Safety Recall
Summary
FDA announces Class II recall of I.T.S. GmbH Olecranonplate medical devices due to updated MRI safety testing showing higher RF-induced temperature increases under certain MRI conditions than previously reflected in Instructions for Use. Recall affects nationwide distribution in multiple states.
What changed
FDA issued a Class II medical device recall for I.T.S. GmbH Olecranonplate products, including Olecranon Hook Plates (Article Numbers: 21112-7, 21114-5, 21113-9) and Olecranon Plates. The recall was initiated after updated MRI safety testing demonstrated higher RF-induced temperature increases under certain MRI conditions than previously disclosed in the Instructions for Use.
Healthcare providers using these orthopedic devices must immediately review MRI safety information, update patient protocols, and communicate changes to clinical staff. Facilities should identify affected inventory by article numbers and follow recall instructions to prevent potential thermal injury during MRI scans in patients with these implants.
What to do next
- Identify and quarantine affected Olecranonplate devices by article numbers
- Review MRI safety protocols for patients who have received these implants
- Update Instructions for Use and communicate changes to relevant clinical staff
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-1597-2026 · 20260401 · Ongoing
Product
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; A...
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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