Robotic Arm Interactive Orthopedic — Class II medical device recall Z-0224-2016
Terminated recall by Mako Surgical Corporation, reported 2015-11-11, distributed nationwide. The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
| Recall number | Z-0224-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Plantation, FL, United States |
| Recall initiated | 2015-07-16 |
| Classified | 2015-11-05 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DE, GB, GR, HK, IT, JP, KR, SG, TR, TW |
| Quantity | 1,322 units |
Product
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
Reason for recall
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
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-0224-2016. 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.