FDA recall Z-0116-2018
Zimmer Biomet, Inc. · Class II · device
Product
ROSA BRAIN 3.0.0
Reason for recall
Non-conforming product label.
Distribution
OH and PA.
Key facts
- Status
- Terminated
- Initiation date
- 2016-07-29
- Report date
- 2017-11-29
- Termination date
- 2020-06-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Warsaw, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0116-2018