Recall Z-2924-2018— Mako Surgical Corporation

Name: FDA recall Z-2924-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-24

Class II · Terminated

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2018-07-24, terminated 2022-10-11. It names one FDA 510(k) clearance: K112507. Product: Stryker Mako Vizadisc Knee Procedure Tracking Kit. Reason: Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-07-24
Terminated: 2022-10-11
Firm location: Davie, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K112507 — RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEMMako Surgical Corporation·cleared 2012-03-01

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 Mako Vizadisc Knee Procedure Tracking Kit

Reason for recall

Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.

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