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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 System see related information
Date Initiated by Firm July 16, 2015
Date Posted November 05, 2015
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-0224-2016
Recall Event ID 72224
510(K)Number K112507  K121064  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
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.
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 Contact Clayton 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
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 in Commerce 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, Australia, Singapore, Taiwan, and South Korea.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OLO and Original Applicant = MAKO SURGICAL CORPORATION
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