Z-0915-2009

Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002. Manufactured by: MAKO...

Name: Z-0915-2009 Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002. Manufactured by: MAKO...
Creator: Mako Surgical Corporation
Published: 2008-05-02
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2008-05-02 / Terminated / root cause: design

FDA source

Mako Surgical Corporation began a recall of Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002. Manufactured by: MAKO Surgical, Corp. The devices are accessories used with... on 2008-05-02. The reason FDA records is "The product in its current state may fail during use, which would cause the instrument to be in-accurate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0915-2009
Status: Terminated
Initiated: 2008-05-02
Posted: 2009-02-11
Terminated: 2009-08-21
Recalling firm: Mako Surgical Corp.
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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: The product in its current state may fail during use, which would cause the instrument to be in-accurate.
Root cause tag: design
FDA 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 in commerce: 44
Distribution: Nationwide Distribution USA including states of FL, NY, CA, TX, GA, TN, NC and PA.
Product codes and lots: 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).

Product code HAW

K072806Class IIMako Surgical Tactile Guidance System (Tgs)Mako Surgical Corp. / cleared 2008-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)