CLASS II Device recall · Reported 29 Nov 2017 · FDA Enforcement Report
ROSA Brain 0 Intended for the spatial positioning recalled
Zimmer Biomet is recalling ROSA Brain 0 Intended for the spatial positioning and orientation of instrument holders, distributed nationwide in the US. The recall was initiated on 27 May 2016 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-0105-2018
- FDA event ID
- 77742
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 May 2016
- FDA classified
- 17 Nov 2017
- Reported
- 29 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 27 May 2016 | Recall initiated by company | |
| 17 Nov 2017 | Classified by FDA | +539 days |
| 29 Nov 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
Product as listed by the FDA
ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
Where it was distributed
Worldwide Distribution - US (DC) and Internationally to Australia and France.
Questions about this recall
Is ROSA Brain 0 Intended for the spatial positioning and orientation of instrument holders recalled?
Yes. Zimmer Biomet recalled ROSA Brain 0 Intended for the spatial positioning and orientation of instrument holders on 27 May 2016. The recall is Class II and its status is Terminated. Recall number Z-0105-2018.
Why was it recalled?
Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
Which lots are affected?
Serial No. BR16004, BR15002, and BR15003
Where was it sold?
Worldwide Distribution - US (DC) and Internationally to Australia and France.
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 21 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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