CLASS II Device recall · Reported 6 Dec 2017 · FDA Enforcement Report
Rosa Surgical Device 2.5.8 Rosa Surgical Device recalled
Zimmer Biomet is recalling Rosa Surgical Device 2.5.8 Rosa Surgical Device is a computer-controlled, distributed nationwide in the US. The recall was initiated on 5 Sep 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0184-2018
- FDA event ID
- 78362
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Sep 2014
- FDA classified
- 28 Nov 2017
- Reported
- 6 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 5 Sep 2014 | Recall initiated by company | |
| 28 Nov 2017 | Classified by FDA | +1180 days |
| 6 Dec 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
Where it was distributed
Nationwide Distribution to AK, OH, TX, GA, and MI
Questions about this recall
Why was it recalled?
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
Which lots are affected?
Serial #'s: RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033 and RO14035
Where was it sold?
Nationwide Distribution to AK, OH, TX, GA, and MI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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