Recall Z-1823-2019— Mako Surgical Corporation

Name: FDA recall Z-1823-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-25

Class II · Terminated

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2019-04-25, terminated 2021-04-22. It names one FDA 510(k) clearance: K143752. Product: 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only). Reason: The bearings of the saw attachments were ungreased..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-04-25
Terminated: 2021-04-22
Firm location: Davie, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K143752 — Total Knee Application (TKA)Mako Surgical Corp.·cleared 2015-08-06

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

2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)

Reason for recall

The bearings of the saw attachments were ungreased.

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