Restoris Partial Knee Application — Class II medical device recall Z-1128-2015
Terminated recall by Mako Surgical Corporation, reported 2015-02-25, distributed nationwide. When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the st
| Recall number | Z-1128-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Plantation, FL, United States |
| Recall initiated | 2015-01-22 |
| Classified | 2015-02-19 |
| Reported by FDA | 2015-02-25 |
| Terminated | 2016-12-14 |
| Distributed | Nationwide (US) |
| Quantity | 228 units |
| Model numbers | 201000, 203999, 207300, 209930 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1128-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.