Recall Z-1132-2014— Mako Surgical Corporation

Name: FDA recall Z-1132-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-09

Class II · Terminated

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2014-01-09, terminated 2014-08-14. It names one FDA 510(k) clearance: K090763. Product: Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.. Reason: The product may be mislabeled and could result in the incorrect implant being used..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-01-09
Terminated: 2014-08-14
Firm location: Plantation, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMMako Surgical Corporation·cleared 2009-06-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.

Reason for recall

The product may be mislabeled and could result in the incorrect implant being used.

Data sourced from openFDA. This site is unofficial and independent of the FDA.