Alphatec Spine
6 federal recalls on file, showing the 3 from the last 12 months. 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
The SafeOp Patient Interface (REF: AIX11240), part of the SafeOp 3 Neural Informatix System used during spine surgery, can lose or drop its nerve monitoring signal due to a software problem. When this happens, the device may show system errors, lose connection to the surgeon's tablet, and require a restart—potentially extending surgery time or changing the surgical plan.
- 2026-02-18FDA-DeviceClass IIStop using Alphatec Spine navigation osteotome
Alphatec Spine has recalled a surgical instrument (ATEC Lateral Navigation Disc Prep Osteotome 10mm) used in spine surgery procedures. The instrument has a design defect where the connection to the Medtronic navigation tracking system does not fit correctly, which could affect its safe operation during surgery.
- 2026-02-18FDA-DeviceClass IIStop using Alphatec ATEC Navigation Osteotome instruments
Alphatec Spine has recalled its ATEC Lateral Navigation Disc Prep Osteotome (10mm, model 266-01-000-10-N) used in spinal surgery due to an incorrect connection geometry in the navigated array. This defect could affect how the instrument connects to the Medtronic StealthStation navigation system during surgery. Seven units were distributed across 14 U.S. states.
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