Device product
Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
Z-0546-2020
Product summary
- Firm
- SPINEART SA
- Event
- Event 84219
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14 pieces distribtued to 1 US Distributor
- Official record key
device-enforcement:Z-0546-2020
Official wording
Reason: Inner blister pack label is incorrect and does not match the correct external box label.
Code information: Model Number: JUT-OX 28 09-S Lot Number: 4-2899 UDI: (01) 0 7640178 97398 5 (11) 181102 (17) 261101 (10) 4-2899
Distribution pattern: US: CA OUS: Unknowns
Derived failure modes
-
Labeling or packaging
label is incorrect