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Automatic Registration
Brainlab SE · Model 2.6 · UDI-DI 04056481145101
3
510(k) clearances
20,634
Adverse events (13 deaths)
114
Recalls
383
Facilities
Description
The Automatic Registration - is a software module, that when used with a compatible computer workstation and compatible registration accessories provides a “registration” for subsequent navigation applications.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-28 | Intellijoint Surgical, Inc. | A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an |
| 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. |
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Get your free API keyRead the docsData 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.