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U.S. Department of Health and Human Services

Class 2 Device Recall Robotic Arm Interactive Orthopedic System

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 Class 2 Device Recall Robotic Arm Interactive Orthopedic Systemsee related information
Date Initiated by FirmJuly 16, 2015
Date PostedNovember 05, 2015
Recall Status1 Terminated 3 on December 14, 2016
Recall NumberZ-0224-2016
Recall Event ID 72224
510(K)NumberK112507 K121064 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductRobotic 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.
Code Information Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000, 203999, 207300 and 209930. Lot/Serial Number: All RIO's.
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Plantation FL 33317-7424
For Additional Information ContactClayton Odor
954-628-0502
Manufacturer Reason
for Recall		The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
FDA Determined
Cause 2		Device Design
ActionAs 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 in Commerce1,322 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OLO
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