FDA Device recall Z-0102-2018
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 ho…
- FDA Device
- Class II
- terminated
- Published 2017-11-22
On 2017-11-22 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 ho… by Zimmer Biomet, citing an undetected shift between the information displayed in the navigation software and the actual patient anatomy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0102-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-14 |
| Published | 2017-11-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | MI, OH, TX |
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
Reason
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
Identifiers
| code_info | Serial #s; RO10009, RO10011, RO10014, and RO13023 |
|---|
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-0102-2018%22
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