FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH headless compression screws recalled for increased MRI heating risk
BURNNationwide distribution
Check your surgical implant lot number
I.T.S. GmbH headless compression screws used in orthopedic surgery may heat up more than expected during MRI scans under certain conditions. Updated safety testing found higher temperature increases than the original instructions stated. This affects specific lot numbers of these implants distributed across the United States.
- If you have one of these screws implanted, contact your surgeon or orthopedic clinic with your implant lot number
- Ask your doctor about MRI safety precautions before scheduling an MRI scan
- Do not delay necessary medical imaging—discuss options with your healthcare provider
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
623 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1606-2026More I.T.S. GmbH recalls
- 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
- FDA-Device2026-04-01I.T.S. GmbH distal humeral plates recalled for higher MRI heating than labeled
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