FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH clavicle plates recalled for higher MRI heating risk
What this means
I.T.S. GmbH clavicle plates used in shoulder surgery may heat up more than expected during MRI scans under certain conditions. New testing found higher temperature increases than the original instructions stated. This affects specific article numbers and lot numbers distributed across the US.
- If you have one of these clavicle plates, contact your surgeon or hospital before having an MRI scan.
- Ask your doctor about the specific article and lot number of your implant.
- Discuss MRI safety precautions with your medical team before any imaging procedure.
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
322 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1593-2026Want us to check the next one for you?
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