Medos International Sarl: Orthopedic Stereotaxic Instrument
- Recalling firm
- Medos International Sarl
- Product
- Velys Enabling Tech Robotic-Assist Station REF: 451611001
- Reason
- Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-23
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e29372b8-6e9d-438b-ac28-5225c08d762f