FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH humeral head plate recalled for MRI safety labeling issue
What this means
I.T.S. GmbH issued a recall for certain Humeral Head Plate with Angular Stability implants used in shoulder surgery. Testing found the device may heat up more than expected during MRI scans under certain conditions. The product labeling did not reflect these updated safety findings.
- If you have received this implant, contact your surgeon with your implant article and lot number
- Tell any healthcare provider about this implant before undergoing an MRI scan
- Ask your doctor whether MRI is safe for you or if alternative imaging is needed
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
292 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
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, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1594-2026Want us to check the next one for you?
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