RegWardenFDA facility compliance records
Facility

MEDOS INTERNATIONAL SARL

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

Activity by year

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

Devices registered here (1)

  • Intervertebral Fusion Device With Bone Graft, Lumbar
    Product code MAX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3080

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.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MEDOS INTERNATIONAL SARL (FEI 3008114965) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008114965-medos-international-sarl/

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