What incidents have involved ROSA?

Every incident, most recent first

1. FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly

   catastrophicrecallFDArecall ordered
   2026-06-15
2. Zimmer ROSA Recon: force sensor error and unintended robotic-arm drift during a knee case (FDA MAUDE)

   seriousmalfunctionFDA (MAUDE)none
   2026-04-01
3. Zimmer ROSA Recon: a large amount of sparks with a hole found in the power cord (FDA MAUDE)

   seriousmalfunctionFDA (MAUDE)none
   2026-03-09
4. Zimmer ROSA Recon: reaming produced an oblong hole requiring a bone graft (FDA MAUDE)

   seriousinjuryFDA (MAUDE)none
   2024-06-24
5. Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory

   criticalrecallFDArecall ordered
   2021-09-22
6. Zimmer Biomet recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory

   criticalrecallFDArecall ordered
   2019-09-10
7. Zimmer Biomet recalls ROSA Spine 1.0.2 over the robotic arm being sent to the wrong position

   seriousrecallFDArecall ordered
   2017-05-01
8. Zimmer Biomet recalls ROSA Brain 3.0 over the robotic arm being sent to the wrong position

   seriousrecallFDArecall ordered
   2017-05-01
9. Zimmer Biomet recalls ROSA Brain 3.0.0 over the head holder connector locking up when tightened

   seriousrecallFDArecall ordered
   2016-10-11
10. Zimmer Biomet recalls ROSA Brain 3.0 over insufficient washers allowing telescopic-arm movement

    seriousrecallFDArecall ordered
    2016-05-27
11. Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over software changing final tool orientation without command

    seriousrecallFDArecall ordered
    2016-04-08
12. Zimmer Biomet recalls ROSA Herga Foot Switch over system freeze or shutdown in Fulgurate mode

    seriousrecallFDArecall ordered
    2016-01-20
13. Zimmer Biomet ROSA 2.5.8 recalled over a force-feedback sensor failure that can stop the arm from halting

    seriousrecallFDArecall ordered
    2014-11-06
14. Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over an undetected shift between navigation display and patient anatomy

    seriousrecallFDArecall ordered
    2014-02-14
15. Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over observed device instability

    seriousrecallFDArecall ordered
    2013-02-05