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

• Date Initiated by Firm: May 02, 2008
• Date Posted: February 11, 2009
• Recall Status: Terminated 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: 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