Devices

Device Recall MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)

Model / Serial
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 Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution USA including states of FL, NY, CA, TX, GA, TN, NC and PA.
Product Description
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.
Manufacturer
Mako Surgical Corporation
1 Event
- Recall of Device Recall MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)

Manufacturer

Mako Surgical Corporation

Manufacturer Address
Mako Surgical Corporation, 2555 Davie Rd Ste 110, Davie FL 33317-7424
Source
USFDA

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