FDA Device recall Z-0224-2016
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector)
- FDA Device
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector) by Mako Surgical, citing the locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0224-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-16 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mako Surgical |
| Distribution | US |
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
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
Identifiers
| code_info | Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000, 203999, 207300 and 209930. Lot/Serial Number: All RIO's. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0224-2016%22
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