Dynamis Robotic Surgical System
LEM Surgical AG · Model TPL0001 · UDI-DI 07649998256025
Description
The Dynamis System is an integrated navigation-based robotic platform with real-time tracking capability for spine surgical procedures that include thoracic, lumbar, and sacral approaches. Dynamis is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding qualified surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans. The system is indicated for the placement of non-cervical spinal pedicle screws and is intended for use with any legally marketed spinal system that contains instruments meeting the criteria for use with the Dynacan end effectors of the Dynamis System.
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 |
| 2026-08-20 | Think Surgical, Inc. | Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling. |
| 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. |
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