Total Hip Application — Class II medical device recall Z-3131-2017
Terminated recall by Mako Surgical Corporation, reported 2017-09-20, distributed nationwide. Software discrepancy of not showing all the EE constants, when the screen is filled.
| Recall number | Z-3131-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Davie, FL, United States |
| Recall initiated | 2017-08-07 |
| Classified | 2017-09-12 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2019-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN, DE, GB, GR, HK, IE, IN, IT, JP, KR, LU, NL, SG, TH, TR, TW, VN, ZA |
| Reason classes | software |
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 for recall
Software discrepancy of not showing all the EE constants, when the screen is filled.
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-3131-2017. 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.