FDA recall Z-1824-2019

Product

2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)

Reason for recall

The bearings of the saw attachments were ungreased.

Distribution

AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands

Key facts

Status

Terminated

Initiation date

2019-04-25

Report date

2019-06-26

Termination date

2021-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1824-2019