Z-0224-2016 Class II Terminated
FDA device recall Z-0224-2016 was initiated by Mako Surgical Corporation on July 16, 2015 and is designated Class II. Reason for recall: The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. The recall status is terminated (terminated December 14, 2016). Affected quantity: 1,322 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2015
- Initiation Date
- July 16, 2015
- Termination Date
- December 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,322 units
Product Description
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.
Reason for Recall
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
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.
Code Information
Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000, 203999, 207300 and 209930. Lot/Serial Number: All RIO's.