The FDA has posted 23 enforcement recalls of orthopedic stereotaxic instrument devices since 2025, none of them Class I (most serious). Most recent report: Jul 15, 2026.
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.
The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments.…
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
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.