FDA Device recall Z-3182-2018
Makoplasty RIO Standard System
- FDA Device
- Class II
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of Makoplasty RIO Standard System by Mako Surgical, citing communication-connection error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3182-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-27 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mako Surgical |
| Distribution | US |
Product
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.
Reason
Communication-connection error.
Identifiers
| code_info | 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-3182-2018%22
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