Medical device recalls Moderate risk

Mako Surgical Corporation recalls Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery Sy…

Recall date
August 8, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1735-2022
FDA classification
Class II
Brand / firm
Mako Surgical Corporation
Sold / distributed
US Distribution was made to IL and AZ.

Why it was recalled

Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.

Get recall alerts

Free email alert whenever Mako Surgical Corporation has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Mako Surgical Corporation