What Happened

The recall was initiated because updated MRI safety testing revealed higher RF-induced temperature increases under certain MRI conditions than what was previously reflected in the Instructions for Use (IFU).

Which Products Are Affected

The affected products are the I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System. Specific items include: 1. I.T.S. DUL System, Distal Ulna Plate with article numbers 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, and 21235-4. 2. I.T.S. UOL System, Ulna Osteotomy Plate with article number 21231-6. 3. UOL System, Cancellous Screw, Locking with article numbers 37302-18 and 37302-20. The recall involves 120 units distributed nationwide 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, and W. Corresponding lot numbers are: For article 21232-3 (26/F65636), 21232-4 (26/F61722, 26/F65637), and others as listed in the source data. The official recall number is Z-1604-2026.

What You Should Do

Consumers should follow the initial firm notification, which was sent via E-mail, and contact the recalling firm, I.T.S. GmbH at Autal 28, Lasnitzhohe, Austria, for information on returns or refunds related to this voluntary recall.

Why This Matters

This recall affects 120 units of medical devices used in procedures, potentially impacting patient safety during MRI scans due to inaccurate safety information in the IFU.

Source

This information is from the FDA recall with number Z-1604-2026. Attribution: FDA (https://www.fda.gov)