What Happened

I.T.S. GmbH is recalling certain Clavicula plates because updated MRI safety testing revealed higher RF-induced temperature increases under specific MRI conditions than what was previously stated in the Instructions for Use (IFU). This is a Class II recall initiated voluntarily by the firm.

Which Products Are Affected

The affected products include the following Clavicula plates with their associated article numbers and lot numbers: 1. Anterior Clavicle Plate, Medial with article numbers 21116-8 (Lot: 679/092230), 21117-10 (Lots: 679/032313, 679/092231), 21118-10 (Lots: 679/032314, 679/072047, 679/092232). 2. Clavicle Plate with article numbers 21121-6 (Lots: 679/092236, 679/092329), 21121-8 (Lot: 679/052226). 3. Clavicle Plate, 3.5mm with article numbers 21122-10 (Lots: 00/0425-02, 00/0825-02, 679/022443, 679/062310, 86/043372), 21122-6 (Lots: 00/0325-01, 00/0425-01, 679/042340, 679/062334, 679/122269, 86/043366), 21122-8 (Lots: 00/0325-08, 679/022243, 679/022304, 679/022451, 679/042209, 679/042214, 679/052319, 679/102368, 86/043368). 4. Clavicle Plate, Lateral with article numbers 21123-4 (Lots: 00/0810-06, 679/052014, 679/062216), 21124-4 (Lots: 679/042333, 679/062217, 679/072346), 21127-6 (Lot: 679/052228), 21128-6 (Lot: 679/042341). A total of 322 units are affected, distributed nationwide in the United States, specifically in states including 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. The official recall number is Z-1593-2026.

What You Should Do

Consumers who have received an e-mail notification from I.T.S. GmbH should follow the instructions provided in that notification. Contact the recalling firm at I.T.S. GmbH, Autal 28, Lasnitzhohe, Austria, for further information on returns or refunds.

Why This Matters

This recall addresses potential safety risks associated with MRI procedures, which could affect patients using these devices and underscores the importance of accurate medical device labeling for patient safety.

Source

This information is from the FDA. For more details, visit the FDA website at https://www.fda.gov/ and search for recall number Z-1593-2026.