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Anatomic Access LLIF

Tyber Medical, LLC · Model NAV81020018 · UDI-DI 00196449033713

OLO Prescription

510(k) clearances

20,328

Adverse events (13 deaths)

113

Recalls

382

Facilities

Description

NAV Anatomic Access LLIF, Cobb, 18mm

Recalls

Date	Firm	Reason
2026-07-23	Medos International Sarl	Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
2026-05-08	Think Surgical, Inc.	Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
2026-04-23	Kico Knee Innovation Company	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.
2026-04-23	Kico Knee Innovation Company	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.
2026-02-10	Orthalign, Inc	Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
2026-02-10	Orthalign, Inc	Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
2026-02-02	Howmedica Osteonics Corp.	A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw
2026-01-02	Alphatec Spine, Inc.	Due a design issue where the navigated array connection geometry is incorrect.
2026-01-02	Alphatec Spine, Inc.	Due a design issue where the navigated array connection geometry is incorrect.
2025-12-10	Mazor Robotics Ltd	Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.