RegWardenFDA facility compliance records
Company

Medos International SARL

2 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2024: 1 recalls; 2026: 1 recalls201720182019202020212022202312024202512026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-07-23
    Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
  • Class IOngoing2024-02-02
    Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Medos International SARL — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10031083-medos-international-sarl/

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