FDA Device recall Z-1128-2015
Restoris Partial Knee Application (PKA) RIO (TGS 2.0)
- FDA Device
- Class II
- terminated
- Published 2015-02-25
On 2015-02-25 the FDA classified a Class II recall of Restoris Partial Knee Application (PKA) RIO (TGS 2.0) by Mako Surgical, citing when using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and tr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1128-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-22 |
| Published | 2015-02-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mako Surgical |
| Distribution | US |
Product
Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
Reason
When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated
Identifiers
| code_info | All lots, Part Numbers: 201000, 203999, 207300, and 209930. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1128-2015%22
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