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.
This recall has been terminated (originally issued November 5, 2015).
- Company
- Mako Surgical Corporation
- Recall Initiated
- July 16, 2015
- Posted
- November 5, 2015
- Terminated
- December 14, 2016
- Recall Number
- Z-0224-2016
- Quantity
- 1,322 units
- Firm Location
- Plantation, FL
- Official Source
- View on FDA website ↗
Reason for Recall
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
Distribution
Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and HI, and the countries of Italy, Japan, Hong Kong, Scotland, Germany, Turkey, Greece, Australia, Singapore, Taiwan, and South Korea.
Lot / Code Info
Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000, 203999, 207300 and 209930. Lot/Serial Number: All RIO's.
Root Cause
Device Design
Action Taken
As of July 16, 2015, Mako communicated by mail the nature of the recall to their Product Specialists and the OR Administrators describing the specifics regarding the issue for correction.