I.T.S. GmbH is recalling the FR.O.H. Calcaneus Repair System, Anterolateral Calcaneus Plate, 4 units, distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact I.T.S. GmbH or your healthcare provider for instructions. Notification method: E-Mail
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Product: FR.O.H. Calcaneus Repair System, Anterolateral Calcaneus Plate Article Number: 21064-60 Lot Numbers: 679/012318, 679/0722100 Sold in: United States nationwide (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) Recall Date: 2026-01-23 Quantity Recalled: 4 Manufacturer: I.T.S. GmbH Price: Unknown Sold Through: Healthcare providers and distribution channels in the US (not consumer retail)
MRI safety testing demonstrated higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use. The condition could cause tissue heating during MRI scans in patients with the implant.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions provided by the manufacturer. 3. Contact I.T.S. GmbH or your healthcare provider for instructions. 4. Look for the recall notification by email and confirm if your device is included. 5. If you need guidance, coordinate with your healthcare provider to determine the next steps.
Manufacturer: I.T.S. GmbH Recall Notification Method: Email FDA Recall Page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1595-2026
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