JULIET Ti LL — Class II medical device recall Z-1426-2023
Ongoing recall by SPINEART SA, reported 2023-05-03, distributed nationwide. JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during
| Recall number | Z-1426-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SPINEART SA, Plan-Les-Ouates, N/A, Switzerland |
| Recall initiated | 2023-03-16 |
| Classified | 2023-04-24 |
| Reported by FDA | 2023-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 544 |
| UPC / GTIN / UDI-DI | 07640178987388, 07640178987395, 07640178987401, 07640178987418, 07640178987425, 07640178987456, 07640178987463, 07640178987470, 07640178987487, 07640178987494, 07640178987500 |
| Lot numbers | 08-S/07640178987388/4-8826, 08-S/07640178987456/4-8845, 10-S/07640178987395/6-5488, 10-S/07640178987463/4-8831, 12-S/07640178987401/6-5489, 12-S/07640178987470/4-8832, 14-S/07640178987418/5-8439, 14-S/07640178987487/4-3861, 16-S/07640178987425/4-8830, 16-S/07640178987494/5-4150, 18-S/07640178987500/5-4151, 4-8828, 4-8829, 4-8833, 5-0643, 5-0644, 5-2431, 5-4142, 5-4145, 5-4146, 5-4147, 5-4148, 5-4149, 5-5377, 5-5378, 5-5379, 5-5380, 5-8438, 6-0714, 6-0721, 6-0722, 6-0725, 6-0726, 6-3209, 6-3211, 6-3217, 6-4732, 6-4733, 6-4734, 6-4735 and 5 more |
| Model numbers | 08-S, 10-S, 12-S, 14-S, 16-S, 18-S |
Product
JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S
Reason for recall
JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay.
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-1426-2023. 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.