Device 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.
Z-1132-2014
Product summary
- Event
- Event 67444
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 units
- Official record key
device-enforcement:Z-1132-2014
Official wording
Reason: The product may be mislabeled and could result in the incorrect implant being used.
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.
Derived failure modes
-
Labeling or packaging
mislabeled