Robotic Arm Interactive Orthopedic System — Class II medical device recall Z-1508-2016
Terminated recall by Mako Surgical Corporation, reported 2016-04-27, distributed nationwide. Revision of the field manual
| Recall number | Z-1508-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Plantation, FL, United States |
| Recall initiated | 2014-04-30 |
| Classified | 2016-04-18 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2019-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DE, GB, GR, HK, IT, JP, KR, SG, TR, TW |
| Quantity | 249 |
| Model numbers | 203900, 207092 |
Product
Robotic Arm Interactive Orthopedic System (RIO)
Reason for recall
Revision of the field manual
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-1508-2016. 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.