Class II

Medical Device Recall: FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

I.T.S. GmbH · January 23, 2026

Reason for Recall

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

4 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1595-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.