FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH olecranon plates recalled for MRI heating risk
What this means
I.T.S. GmbH olecranon plates and olecranon hook plates used in orthopedic surgery may heat up more than expected during MRI scans under certain conditions. Updated safety testing found higher temperature increases than the original instructions stated.
- If you received an olecranon plate or hook plate from I.T.S. GmbH, contact your surgeon or hospital immediately with your article and lot numbers.
- Before any MRI scan, inform the MRI technician that you have this implant and share the updated safety information from I.T.S. GmbH.
- Do not proceed with MRI until you confirm with your medical team that it is safe given the new testing data.
The agency's original wording
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Intended for
Adults
Illnesses reported
None reported
Sold states
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, SC, TX, USVI, WV, W.
Affected count
70 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
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; Article Numbers: 21111-6, 21111-8, 21111-12.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1597-2026Want us to check the next one for you?
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