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.
FDA Recall Z-0915-2009 · Posted 2009-02-11
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Recalling FirmMako Surgical Corporation
Recall StatusTerminated
Product CodeHAW
Date Initiated2008-05-02
Date Terminated2009-08-21
Product Quantity44
Reason for Recall
The product in its current state may fail during use, which would cause the instrument to be in-accurate.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Nationwide Distribution USA including states of FL, NY, CA, TX, GA, TN, NC and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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