Mako Surgical Corporation: Medical Device Recall in 2022 - (Recall #: Z-1735-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 8, 2022

Date Posted: September 21, 2022

Recall Number: Z-1735-2022

Event ID: 90727

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.

Status: Ongoing

Product Quantity: 2

Code Information:

Lot #22041607, UDI-DI (GTIN) 07613327407280.

Distribution Pattern:

US Distribution was made to IL and AZ.

Voluntary or Mandated:

Voluntary: Firm initiated