FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. orthopedic surgical plates recalled over higher MRI heating risk
What this means
I.T.S. GmbH orthopedic plates used in bone surgery were tested for safety during MRI scans. Testing found these plates can get hotter than originally stated when exposed to certain MRI conditions. The manufacturer has updated safety information to reflect the actual heating levels.
- If you have received one of these plates, contact your surgeon or hospital with your plate article and lot number.
- Before any MRI scan, inform the radiologist and MRI technician that you have an I.T.S. orthopedic plate implanted.
- Review the updated Instructions for Use provided by the manufacturer for new MRI safety guidance.
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
510 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1598-2026Want us to check the next one for you?
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