Class 2 Device Recall FR.O.H. Calcaneus Repair System

• Date Initiated by Firm: January 23, 2026
• Date Posted: March 20, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1595-2026
• Recall Event ID: 98341
• 510(K)Number: K051642
• Product Classification: Plate, fixation, bone - Product Code HRS
• Product: FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
• Code Information: Article Number (Lot Numbers): 21064-60 (679/012318, 679/0722100).
• FEI Number: 3004369035
• Recalling Firm/ Manufacturer: I.T.S. GmbH; Autal 28; Lasnitzhohe Austria
• For Additional Information Contact: 316-211210
• Manufacturer 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).
• FDA Determined Cause: No Marketing Application
• Action: ITS initially notified its importer/distributor on about 01/23/2026 via email. Instructions were to cease distribution, and further information will be provided. An additional notification was sent to distributors and consignees on about 02/04/2026 via email. Instructions included to ensure any IFU different to the provided one is removed from systems and/or destroyed, notify clinical staff managing patients with implants, contact I.T.S. GmbH for any questions or to discuss proper scanning conditions for implanted devices in the interim while they work on labeling and IFU updates for the devices, and arrange for the return of specific originally packaged items - base plates and screws in surgery trays. Other outlined products can continue to be used upon confirmation from ITS. Consignees were also instructed to complete and return the response form. Distributors were instructed to continue to immediately halt product distribution from the U.S. office to sales groups and hospitals, remove the outdated paper IFU from packaging and add the eIFU symbol to product labeling to implement the updated IFU provided electronically - see annex "F-7.5.5-3-US_IFU_non-sterile_Rev00_DRAFT". Paper IFUs will be made available upon request. They were also requested to assist in notification of hospitals.
• Quantity in Commerce: 4 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HRS