FDA Medical Device Recalls (openFDA)
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 number
- Z-0915-2009
- Recalling firm
- Mako Surgical Corporation
- 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.
- Status
- Terminated
- Initiated
- 2008-05-02
- Posted
- 2009-02-11
- Terminated
- 2009-08-21
- Reason
- The product in its current state may fail during use, which would cause the instrument to be in-accurate.
- Root 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
- 44
- Distribution
- Nationwide Distribution USA including states of FL, NY, CA, TX, GA, TN, NC and PA.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- ["K072806"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 3005985723
- Firm city
- Davie
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28