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.
FDA Recall Z-0224-2016 · Posted 2015-11-05
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Recalling FirmMako Surgical Corporation
Recall StatusTerminated
Product CodeOLO
Date Initiated2015-07-16
Date Terminated2016-12-14
Product Quantity1,322 units
Reason for Recall
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
Firm 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.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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