Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–10 of 10 recalls
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 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.
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.
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.