Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.

Recall Insight

This FDA Devices action (record #Z-3182-2018) was formally reported on September 26, 2018, with the manufacturer initiating the action on December 27, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Mako Surgical Corporation is listed as the recalling firm, operating out of Davie, FL. Federal records list the affected scope as 736 (US) and 174 (OUS).

The documented reason for this recall is: Communication-connection error. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of Australia, New Zealand, Taiwan, China, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Germany, Ireland, Switzerland, Italy, India, Japa…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.