Intersomatic JULIET Ti OL cage — Class III medical device recall Z-0546-2020
Terminated recall by SPINEART SA, reported 2019-12-04, distributed in CA. Inner blister pack label is incorrect and does not match the correct external box label.
| Recall number | Z-0546-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SPINEART SA, Plan-Les-Ouates, Switzerland |
| Recall initiated | 2019-02-05 |
| Classified | 2019-11-22 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2021-04-28 |
| Distributed | CA |
| Reason classes | labeling |
| Lot numbers | 4-2899 |
| Model numbers | 09-S |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0546-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.