ITS GmbH recalled 1,307 units of the HLS Hand Locking Plates System distributed nationwide in the United States after MRI safety testing showed higher RF-induced temperature increases. The issue exceeds what is described in the IFU under certain MRI conditions. Patients and healthcare providers should stop using the device immediately and follow ITS GmbH'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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Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20; 21505-4, 21506-4; 21507-4, 21508-4; 21517; 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10; 21513-3, 21513-5, 21514-3, 21514-5; 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20. Sold at: Unknown. When sold: Unknown. Price: Unknown.
MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow ITS GmbH recall instructions or consult your healthcare provider for guidance. 3. If you have this device, arrange removal or return according to the recall. 4. Monitor recall updates from the FDA enforcement page. 5. For questions, contact ITS GmbH using the recall resources.
Phone: Unknown. Website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1607-2026. Hours: Unknown.
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