Recall Z-2051-2018— Mako Surgical Corporation

Name: FDA recall Z-2051-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-19

Class II · Terminated

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2018-01-19, terminated 2020-09-16. It names one FDA 510(k) clearance: K090763. Product: Restoris MCK Onlay Insert Extractor.. Reason: Possible hinge pin disassociation from the Mako Onlay Insert Extractor..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-01-19
Terminated: 2020-09-16
Firm location: Davie, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMMako Surgical Corporation·cleared 2009-06-17

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

Restoris MCK Onlay Insert Extractor.

Reason for recall

Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

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