FDA recall Z-0546-2020
SPINEART SA · Class III · device
Product
Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
Reason for recall
Inner blister pack label is incorrect and does not match the correct external box label.
Distribution
US: CA OUS: Unknowns
Key facts
- Status
- Terminated
- Initiation date
- 2019-02-05
- Report date
- 2019-12-04
- Termination date
- 2021-04-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Plan-Les-Ouates, Switzerland
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0546-2020