MAKO RIO THA Application User Guides — Class II medical device recall Z-1411-2017
Terminated recall by Mako Surgical Corporation, reported 2017-03-15, distributed nationwide. Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
| Recall number | Z-1411-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Davie, FL, United States |
| Recall initiated | 2016-12-22 |
| Classified | 2017-03-07 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2019-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 777 |
| Model numbers | 1.0, 2.0, 2.1, 204863THA, 207116THA, 208692THA, 209711, 210555, 212026THA |
Product
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Reason for recall
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
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-1411-2017. 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.