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U.S. Department of Health and Human Services

Class 2 Device Recall Total Hip Application (THA)

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  Class 2 Device Recall Total Hip Application (THA) see related information
Date Initiated by Firm August 07, 2017
Create Date September 13, 2017
Recall Status1 Open3, Classified
Recall Number Z-3131-2017
Recall Event ID 77950
510(K)Number K121064  K141989  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Total Hip Application (THA)

Product Usage:
The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Code Information All Lot codes
Recalling Firm/
Manufacturer
Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact Clayton Odor
954-628-0502
Manufacturer Reason
for Recall
Software discrepancy of not showing all the EE constants, when the screen is filled.
FDA Determined
Cause 2
Software design
Action There will be no communication to the customer. Notification shall only go to the MAKO Product Specialist and Branch Managers as this action is not a customer facing issue. These letters and acknowledge forms were sent via Federal Express Two Days Air with return receipt.
Quantity in Commerce 291 (US) and 66 (OUS)
Distribution Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY and the countries of Australia, Taiwan, China, Taiwan, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Ireland, Italy, Germany, India, Japan, Korea, Singapore, Thailand, Vietnam, South Africa, and Turkey
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = MAKO SURGICAL CORPORATION
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