Company:Mako Surgical
Date of Enforcement Report 2/25/2009
Class:ll

PRODUCT
a) Femoral Array, Model number: 0150ARR00001 and b) Tibial Array, Model number: 0150ARR00002. 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 # Z-0915-2009

REASON
The product in its current state may fail during use, which would cause the instrument to be in-accurate.

RECALLING FIRM/MANUFACTURER
Mako Surgical Corp., Davie, FL, by letter dated July 1, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
44 units

DISTRIBUTION
Nationwide