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Disposable Reflective Marker Spheres (DRMS)

Northern Digital Inc · Model 41813 · UDI-DI 20805832010036

OLO HAW Prescription

510(k) clearances

20,328

Adverse events (13 deaths)

113

Recalls

382

Facilities

Description

Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 2 spheres per tray, 30 trays, 60 spheres total.

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.