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U.S. Department of Health and Human Services

Class 2 Device Recall MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)

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  Class 2 Device Recall MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) see related information
Date Initiated by Firm May 02, 2008
Date Posted February 11, 2009
Recall Status1 Terminated 3 on August 21, 2009
Recall Number Z-0915-2009
Recall Event ID 48598
510(K)Number K072806  
Product Classification TACTILE GUIDANCE SYSTEM (TGS) - Product Code HAW
Product Tibial Array and Femoral Array.
Model Number(s): 0150ARR00001 and 0150ARR00002.
Manufactured by: MAKO Surgical, Corp.


The devices are accessories used with MAKO's Tactile Guidance System (TGS). The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Code Information Femoral Tray - Model 0150ARR00001, Lot Number/Quantity: 0609038 (6), 06051107 (4), 01010806 (4), 09010108 (2), 06040707-01 (1), 01010107 (3), 01010607 (1), 01010106 (1) and 06040707 (2) and    Tibial Tray - Model 0150ARR00002, Lot Number/Quantity: 06060308 (6), 06061107 (7), 01020866 (2), 01010507 (1), 01020806 (1), 01020107 (3), 09081107 (2) and 01020607 (2).
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact Jim Pomeroy
954-927-2044 Ext. 605
Manufacturer Reason
for Recall		 The product in its current state may fail during use, which would cause the instrument to be in-accurate.
FDA Determined
Cause 2		 Component design/selection
Action A MAKO employee will visually verify product at each account for any product affected by this recall. In addition, a recall letter dated July 1, 2008 was mailed to users (surgeon and owner of system, e.g. hospital). Customers were instructed to complete the enclosed Acknowledgement form and return it to your Clinical Technical Specialist (CTS) or in the enclosed pre-paid addressed envelope to the Mako Surgical Corporation. Please direct questions to your CTS or call 954-927-2044, extension 604.
Quantity in Commerce 44
Distribution Nationwide Distribution USA including states of FL, NY, CA, TX, GA, TN, NC and PA.
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 = HAW and Original Applicant = MAKO SURGICAL CORP.
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