Recall Z-0224-2016 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
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.
| Date | Nov 5, 2015 (initiated Jul 16, 2015) |
| Status | Terminated |
| Reason | The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 1,322 units |
| 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, A |
| FDA record | Open on fda.gov |