Device product
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.
Z-0224-2016
Product summary
- Event
- Event 72224
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,322 units
- Official record key
device-enforcement:Z-0224-2016
Official wording
Reason: The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
Code information: Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000, 203999, 207300 and 209930. Lot/Serial Number: All RIO's.
Distribution pattern: 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.
Derived failure modes
-
Unknown
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.