Recall Z-1644-2018— Mako Surgical Corporation

Name: FDA recall Z-1644-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-01

Class II · Terminated

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2017-12-01, terminated 2020-12-14. It names 2 FDA 510(k) clearances: K170891, K170584. Product: RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.. Reason: Incorrect product and/or label. Sizing is labeled incorrectly..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-12-01
Terminated: 2020-12-14
Firm location: Davie, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K170891 — Mako Partial Knee ApplicationMako Surgical Corp.·cleared 2017-05-24
K170584 — Mako Partial Knee ApplicationMako Surgical Corp.·cleared 2017-05-11

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 TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

Reason for recall

Incorrect product and/or label. Sizing is labeled incorrectly.

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