FDA recall Z-1595-2026

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2026-01-23

Report date

2026-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lasnitzhohe, Austria

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1595-2026