Alphatec Spine
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Alphatec Spine and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-29FDA-DeviceClass IIAlphatec SafeOp Patient Interface recalled for monitoring loss risk
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
- 2026-02-18FDA-DeviceClass IIStop using Alphatec Spine navigation osteotome
Due a design issue where the navigated array connection geometry is incorrect.
- 2026-02-18FDA-DeviceClass IIStop using Alphatec ATEC Navigation Osteotome instruments
Due a design issue where the navigated array connection geometry is incorrect.
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