FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH distal humeral plates recalled for higher MRI heating than labeled
What this means
I.T.S. GmbH distal humeral plates and locking cortical screws used in arm surgery may heat more than expected during MRI scans under certain conditions. New testing found the heating levels are higher than what the original instructions stated.
- If you had arm surgery with an I.T.S. distal humeral plate or cortical screw, contact your surgeon before having an MRI scan
- Provide your surgeon with your implant article number and lot number (found on your implant card or surgical records)
- Ask your surgeon about updated MRI safety guidelines for your specific implant
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
12,059 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
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, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1602-2026Want us to check the next one for you?
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