FDA Device recall Z-0161-2018
ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument hol…
- FDA Device
- Class II
- terminated
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class II recall of ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument hol… by Zimmer Biomet, citing software corrections reactivating the cooperative endoscopy mode.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0161-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-04 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
ROSA Surgical Device 2.5.8 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.
Reason
Software corrections reactivating the cooperative endoscopy mode.
Identifiers
| code_info | Serial No. RO10011, RO14033, RO14031, RO14035, RO13027, RO13023, RO10014, RO10009, RO10010, RO14030, RO11016, RO11017,…Serial No. RO10011, RO14033, RO14031, RO14035, RO13027, RO13023, RO10014, RO10009, RO10010, RO14030, RO11016, RO11017, RO12022, RO14029, RO14032, RO08003, RO09004, RO10007, RO10013, RO12018, RO12019, RO13025, RO14034, RO11015, RO13024, RO09005, RO13026, RO12021, and RO12020. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0161-2018%22
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