FDA Device recall Z-1508-2016
Robotic Arm Interactive Orthopedic System (RIO)
- FDA Device
- Class II
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class II recall of Robotic Arm Interactive Orthopedic System (RIO) by Mako Surgical, citing revision of the field manual.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1508-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-30 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mako Surgical |
| Distribution | US |
Product
Robotic Arm Interactive Orthopedic System (RIO)
Reason
Revision of the field manual
Identifiers
| code_info | Catalog # 203900 & 207092 All lots |
|---|
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-1508-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.