FDA recall Z-0178-2018
Zimmer Biomet, Inc. · Class II · device
Product
ROSA Surgical Device 2.5.8
Reason for recall
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
Distribution
AR, OH, MI, and TX
Key facts
- Status
- Terminated
- Initiation date
- 2013-02-10
- Report date
- 2017-12-06
- Termination date
- 2020-06-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Warsaw, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0178-2018