Systemic testing failure prompts Class II recalls across pelvic, foot, humeral, and other orthopedic devices.
The FDA initiated 14 Class II medical device recalls for I.T.S. GmbH orthopedic implants on April 9-11, 2026, after updated MRI safety testing revealed higher RF-induced temperature increases than previously disclosed. The recalls affect pelvic reconstruction systems, foot locking plates, distal humeral plates, forearm plates, femur plates, and multiple other orthopedic devices.
The systemic quality control failure means patients with these implants face potential burn risks during MRI procedures. The affected devices include the HLS Hand Locking Plates System, Olecranonplate, Claviculaplate, and the FR.O.H. Calcaneus Repair System.
Patients who have received I.T.S. GmbH orthopedic implants should consult their physicians regarding MRI safety and alternative imaging options until the recall is resolved.
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