Recall
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…
Mako Surgical Corporation · 9 Jan 2014
- Status
- Recall terminated
- Why, in the FDA's words
- “The product may be mislabeled and could result in the incorrect implant being used.”
- Recall began
- 9 Jan 2014
- Company
- Mako Surgical Corporation
- Device type
- Product code (NPJ)
- Concerns
- K090763
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.