Recall Z-0167-2018— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-07-20, terminated 2020-06-16. It names one FDA 510(k) clearance: K151359. Product: ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.. Reason: Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-20
- Terminated
- 2020-06-16
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Reason for recall
Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
Data sourced from openFDA. This site is unofficial and independent of the FDA.