Recall Z-3088-2026
- Recall number
- Z-3088-2026
- Event number
- 99467
- Firm
- Medos International Sarl
- Firm FEI
- 3008114965
- Product code
- OLO
- Status
- Open, Classified
- Initiated
- 2026-07-23
- Posted
- 2026-09-02
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K233228, K252088, K130748, K230064, K173946, K162195, K243958, K250086, K162341, K153237, K172219, K252989, K182077, K252742, K083872, K240647, K243326, K220958, K162567, K252873, K240062, K261205, K240568, K190556, K183644, K213033, K201966, K191100, K232800, K232413
Product#
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Reason for Recall#
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.