PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 26, 2019 Initiated: April 25, 2019 #Z-1823-2019

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.

Details

Recalling Firm
Mako Surgical Corporation
Units Affected
39
Distribution
AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
Location
Davie, FL

Frequently Asked Questions

What product was recalled?
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only). Recalled by Mako Surgical Corporation. Units affected: 39.
Why was this product recalled?
The bearings of the saw attachments were ungreased.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 26, 2019. Severity: Moderate. Recall number: Z-1823-2019.