Drug recall
Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
FDA recall event 84219 · Class III · SPINEART SA
Key facts
| Event ID | 84219 |
|---|---|
| Recall numbers | Z-0546-2020 |
| Recalling firm | SPINEART SA |
| Product type | Devices |
| Products | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Inner blister pack label is incorrect and does not match the correct external box label. |
| Initiation date | Feb 5, 2019 |
| Report date | Dec 4, 2019 |
| Termination date | Apr 28, 2021 |
| City | Plan-Les-Ouates |
| Country | Switzerland |
| FEI number | 3007728266 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: