The FDA has posted 10 enforcement recalls of orthopedic stereotaxic instrument devices since 2025, none of them Class I (most serious). Most recent report: Sep 9, 2026.
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment.…
Due a design issue where the navigated array connection geometry is incorrect.
Due a design issue where the navigated array connection geometry is incorrect.
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Orthopedic Stereotaxic Instrument”). Informational only — verify against the FDA before acting.