FDA recall Z-1735-2022

Product

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

Reason for recall

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.

Distribution

US Distribution was made to IL and AZ.

Key facts

Status

Ongoing

Initiation date

2022-08-08

Report date

2022-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1735-2022