Spinal FrontiersPowered by NSpineA defective circuit board, introduced after a supplier change, may deliver unintended stimulation or leakage current to the patient; 23 units went to the US and 15 other countries including Spain, Italy, Belgium and Switzerland.
- Type
- Recall
- Company
- Cadwell Industries
- Device
- IOMAX Cortical Module (190296-200), intraoperative neuromonitoring
- Date
- 18 August 2026
- Jurisdiction
- US
- Classification
- FDA Class II recall (Z-0141-2027; 510(k) K162199)
- Source
- FDA Medical Device Recalls database
Read the official notice →Source checked
What to do
Act on the regulator's or manufacturer's own notice; this page is a summary, not an official safety channel. If a device has failed or harmed a patient, see Report a Device Problem for who to tell in your country.