ITS recalls 869 Fibula Plate PROlock with Angular Stability implants distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than previously reflected in the IFU. Hospitals and healthcare providers should stop using this device immediately and follow the 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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This is an orthopedic implant used to stabilize fibula fractures. It is implanted surgically and remains in the patient after recovery.
MRI exposure can cause RF-induced heating at the implant site. This heating may injure surrounding tissue during scans under certain conditions.
This recall is not part of a broader industry pattern.
The recall affects patients with these implants and hospitals performing MRIs. Imaging decisions may change and patients may need follow-up planning.
Look in your surgical records, implant documentation, and the recall notice. The FDA enforcement page lists all affected article numbers.
Actions by hospitals may occur within weeks to months. Individual timelines depend on clinical circumstances and manufacturer guidance.
Keep copies of recall notices, communication with providers, and imaging decisions. Record dates, names, and actions taken.
Model numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8, 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12, 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16. Sold at: Hospitals and clinics nationwide in the United States. Sold since: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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