Class III — SPINEART SA
| Recalling firm | SPINEART SA |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Inner blister pack label is incorrect and does not match the correct external box label. |
| Product | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures |
| Quantity | 14 pieces distribtued to 1 US Distributor |
| Distribution | US: CA OUS: Unknowns |
| Initiated | 2019-02-05 |
| Classified | 2019-11-22 |
| Terminated | 2021-04-28 |
| Recall number | Z-0546-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — SPINEART SA (Z-0546-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84219/
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