medical Class II Updated 2018-09-26

Mako Surgical Corporation recalls Makoplasty RIO Standard System; Ethernet to Fiber Optic Conv

Recalled Product

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.


Hazard / Issue

Communication-connection error.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: ALL LOTS
View official government recall

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