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.
This recall has been terminated (originally issued February 11, 2009).
- Company
- Mako Surgical Corporation
- Recall Initiated
- May 2, 2008
- Posted
- February 11, 2009
- Terminated
- August 21, 2009
- Recall Number
- Z-0915-2009
- Quantity
- 44
- Firm Location
- Davie, FL
- Official Source
- View on FDA website ↗
Reason for Recall
The product in its current state may fail during use, which would cause the instrument to be in-accurate.
Distribution
Nationwide Distribution USA including states of FL, NY, CA, TX, GA, TN, NC and PA.
Lot / Code Info
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).
Root Cause
Component design/selection
Action Taken
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.