What Happened

I.T.S. GmbH is recalling certain medical devices after updated MRI safety testing showed higher RF-induced temperature increases under specific MRI conditions than what was previously reflected in the Instructions for Use.

Which Products Are Affected

The affected products include:

• Cancellous Screw, Cannulated with article numbers such as 31404-16, 31404-18, up to 31404-80, and others like 31457-30 to 31457-60.
• Cortical Screw, Cannulated with article numbers such as 31357-20 to 31357-70.
• Washer with article number 36851.
• Washer, Concave with article numbers 36432, 36653, and 36732.
• Washer, Flat with article numbers 36431, 36651, 36653, and 36731. Specific lot numbers are associated with these article numbers, and a total of 5,568 units are affected. The products were distributed nationwide in the United States, including states such as AL, AZ, 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, and W. The recall number is Z-1599-2026.

What You Should Do

Consumers and healthcare providers who have the affected products should contact I.T.S. GmbH for instructions, as the recall was initiated via e-mail. For returns or refunds, reach out to the recalling firm at their address: Autal 28, Lasnitzhohe, Austria.

Why This Matters

This recall highlights potential risks associated with medical devices during MRI procedures, emphasizing the need for accurate safety information to prevent possible health issues in 5,568 affected units.

Source

FDA Recall Notice: event ID 98341, recall number Z-1599-2026