FDA recall Z-1823-2019
Mako Surgical Corporation · Class II · device
Product
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
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-1823-2019