FDA Device recall Z-3131-2017
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providi…
- FDA Device
- Class II
- terminated
- Published 2017-09-20
On 2017-09-20 the FDA classified a Class II recall of Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providi… by Mako Surgical, citing software discrepancy of not showing all the EE constants, when the screen is filled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3131-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-07 |
| Published | 2017-09-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mako Surgical |
| Distribution | US |
Product
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Reason
Software discrepancy of not showing all the EE constants, when the screen is filled.
Identifiers
| code_info | All Lot codes |
|---|
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-3131-2017%22
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