FDA Device recall Z-0115-2018
ROSA Surgical Device 2.5.8
- 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 by Zimmer Biomet, citing potential for software to change the final tool orientation for the command position without command.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0115-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-08 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, WA |
Product
ROSA Surgical Device 2.5.8
Reason
Potential for software to change the final tool orientation for the command position without command.
Identifiers
| code_info | Serial No. RO15050, RO15044, RO15048, RO15067, RO15045, RO15061, RO14041, RO14038, RO14039, RO14043, RO15051, RO15069,…Serial No. RO15050, RO15044, RO15048, RO15067, RO15045, RO15061, RO14041, RO14038, RO14039, RO14043, RO15051, RO15069, RO10011, RO14037, RO10014, RO15054, RO14035, RO15060, RO15063, RO14033, RO15059, RO15064, RO14031, RO14040, RO10009, RO13023, RO15053, RO15052, RO15058, RO13027, RO15046, and RO15062 |
|---|
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-0115-2018%22
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