Mako Surgical Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Mako Surgical Corporation
Lot Codes / Batch Numbers
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).
Products Sold
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).
Mako Surgical Corporation is recalling Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002. Manufactured by: MA due to The product in its current state may fail during use, which would cause the instrument to be in-accurate.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product in its current state may fail during use, which would cause the instrument to be in-accurate.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026