FDA Device recall Z-0178-2018
ROSA Surgical Device 2.5.8
- FDA Device
- Class II
- terminated
- Published 2017-12-06
On 2017-12-06 the FDA classified a Class II recall of ROSA Surgical Device 2.5.8 by Zimmer Biomet, citing issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0178-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-10 |
| Published | 2017-12-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | AR, MI, OH, TX |
Product
ROSA Surgical Device 2.5.8
Reason
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
Identifiers
| code_info | Serial No. RO10011, RO10014, RO13023 and RO13027 |
|---|
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-0178-2018%22
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