Mako Surgical Corporation: Medical Device Recall in 2014 - (Recall #: Z-1132-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 9, 2014

Date Posted: March 12, 2014

Recall Number: Z-1132-2014

Event ID: 67444

Reason for Recall:

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

Status: Terminated

Product Quantity: 41 units

Code Information:

Part Number #180704-1, Lot #12151013-1.

Distribution Pattern:

Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN.

Voluntary or Mandated:

Voluntary: Firm initiated