Recall of HLS Hand Locking Plates System by I.T.S. GmbH
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I.T.S. GmbH is voluntarily recalling 1,307 units of HLS Hand Locking Plates System due to updated MRI safety testing showing higher temperature increases than previously indicated.
What this FDA recall tells you, and what most readers miss
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Recall of HLS Hand Locking Plates System
What Happened
I.T.S. GmbH is recalling certain HLS Hand Locking Plates System products because updated MRI safety testing has demonstrated higher RF-induced temperature increases under specific MRI conditions than what was previously stated in the Instructions for Use (IFU). This is a Class II recall initiated voluntarily by the firm.
Which Products Are Affected
The affected products include various HLS Hand Locking Plates and screws with the following descriptions and article numbers: 1. Cortical Screw with 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; 2. HLS Plate, 2 T-Shape with article numbers 21505-4, 21506-4; 3. HLS Plate, 3 T-Shape with article numbers 21507-4, 21508-4; 4. HLS Plate, Square with article number 21517; 5. HLS Plate, Straight with article numbers 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10; 6. HLS Plate, Y-Shape with article numbers 21513-3, 21513-5, 21514-3, 21514-5; 7. Locking Stabilization Screw with article numbers 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. Specific lot numbers are associated with these article numbers, and a total of 1,307 units are affected. The products were distributed nationwide in the United States, specifically 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, and W. The recall number is Z-1607-2026.
What You Should Do
Consumers who have been notified via email by I.T.S. GmbH should follow the instructions provided in the notification regarding the affected products. Contact the recalling firm for further guidance on returns or replacements.
Why This Matters
This recall ensures that medical devices meet updated safety standards for MRI procedures, potentially preventing adverse health effects from excessive heating. It highlights the importance of accurate safety information in medical devices to protect patient health.
Source
FDA recall information, recall number Z-1607-2026. For more details, visit the FDA website.
Original source: FDA Official Notice ↗
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