Recall Z-0915-2009 ยท HAW Neurological Stereotaxic Instrument
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 procedu
| Date | Feb 11, 2009 (initiated May 2, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072806 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) Mako Surgical Corp., Jan 24, 2008 |