FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH clavicle plates recalled for higher MRI heating risk
BURNNationwide distribution
Contact your surgeon about I.T.S. clavicle plate
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.
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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-1593-2026More I.T.S. GmbH recalls
- FDA-Device2026-04-01I.T.S. GmbH headless compression screws recalled for increased MRI heating risk
- FDA-Device2026-04-01I.T.S. GmbH foot and hallux osteotomy locking plates recalled for MRI safety concerns
- FDA-Device2026-04-01I.T.S. GmbH olecranon plates recalled for MRI heating risk
- FDA-Device2026-04-01I.T.S. Screw System recalled for higher MRI-induced heating than labeled
- FDA-Device2026-04-01I.T.S. GmbH HLS Hand Locking Plates System recalled for higher MRI temperature risk
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief