Recall Z-1735-2022— Mako Surgical Corporation

Name: FDA recall Z-1735-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-08

Class II · Ongoing

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2022-08-08. It names one FDA 510(k) clearance: K121064. Product: Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.. Reason: 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..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-08-08
Firm location: Weston, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K121064 — MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMMako Surgical Corporation·cleared 2012-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.