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.
Reported: September 26, 2018 Initiated: December 27, 2017 #Z-3182-2018
Product Description
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.
Reason for Recall
Communication-connection error.
Details
- Recalling Firm
- Mako Surgical Corporation
- Units Affected
- 736 (US) and 174 (OUS)
- Distribution
- 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, Japan, South Korea, Vietnam, South Africa, and Turkey,
- Location
- Davie, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mako Surgical Corporation. Units affected: 736 (US) and 174 (OUS).
Why was this product recalled? ▼
Communication-connection error.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3182-2018.
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