Recall Record

Le Locle, N/A, Switzerland

Medos International Sarl recalls

2 recalls recorded since 2018, most recently on 23 July 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)1

Ongoing Class II Medical devices

Recall started
23 July 2026
Reason
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Distribution
US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
Initiated
Voluntary: Firm initiated
Recall number
Z-3088-2026

Ongoing Class I Medical devices

Recall started
2 February 2024
Reason
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.
Distribution
Worldwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-1284-2024

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.