I.T.S. GmbH is recalling approximately 84,406 units of various orthopedic plates and screws, including Radius, Clavicle, Humeral, and Foot locking systems, due to updated safety testing. The testing revealed that under certain MRI conditions, these implants can experience higher temperature increases from radiofrequency energy than what was previously stated in the user instructions. The recall affects a wide range of surgical implants distributed nationwide across nearly 30 states.
Patients with these implants who undergo an MRI scan may be at risk for thermal injury or burns because the devices can overheat more than expected during the procedure. No specific injuries have been reported in the data, but the updated safety limits are higher than those originally reflected in the Instructions for Use.
Recall Number Z-1592-2026
Recall Number Z-1593-2026
Recall Number Z-1594-2026
Recall Number Z-1595-2026
Recall Number Z-1596-2026
Recall Number Z-1597-2026
Recall Number Z-1598-2026
Recall Number Z-1599-2026
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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