Robotic Arm Interactive Orthopedic System (RIO)
This recall has been terminated (originally issued April 18, 2016).
- Company
- Mako Surgical Corporation
- Recall Initiated
- April 30, 2014
- Posted
- April 18, 2016
- Terminated
- July 24, 2019
- Recall Number
- Z-1508-2016
- Quantity
- 249
- Firm Location
- Plantation, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Revision of the field manual
Distribution
Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.
Lot / Code Info
Catalog # 203900 & 207092 All lots
Root Cause
Process control
Action Taken
As per our conversation with firm representative on March 23, 2016, they stated "no notification was sent to the customers", and referred to Ref: Part 806 File number: RA 2015-017 where it states "Stryker Orthopaedics has completed a retrospective review of other revisions to the field service manual, and we have confirmed there are no other similar events for which Part 806 reports should have been submitted". For further questions, please call (866) 647-6256. Internal actions taken only.