Z-1426-2023Class II

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...

Name: Z-1426-2023 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...
Creator: Spineart Sa
Published: 2023-03-16
License: https://open.fda.gov/license/

Spineart SA / initiated 2023-03-16 / Open, Classified

FDA source

SPINEART SA began a recall of 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... on 2023-03-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1426-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-16
Posted: 2023-04-24
Recalling firm: Spineart SA
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
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
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.
FDA root cause: Process change control
Action: On 3/16/23, recall notices were distributed to customers who were told the following: Plate replacement: If the issue occurs, the surgeon should proceed as follows: 1- Unscrew the Plate screw of the cage with the screwdriver, 2- Scrap the current plate assembly, 3- Use a new set of pre-assembled plate/screw (a minimum of 2 sets of pre-assembled plates/screws per size are part of the device listing). The cages are to be used with the corresponding plate or higher plate which means that a plate with the same height than the cage can be used but also a plate with higher height. 4- In the case of 0-degree and 8-degree cages, a pre-assembled plate/screw is not mandatory as described in the surgical technique Acknowledge receipt of this letter by emailing to [email protected] Discontinue use and return any product on hand. Customers with questions can contact firm at 949-313-6400 Monday through Friday, 8:00am to 5:00pm, Pacific, or email at [email protected]
Quantity in commerce: 544
Distribution: US Nationwide distribution in the states of NH, TX, CA, VA, IL, RI, NC, AZ.
Product codes and lots: REF/UDI-DI/Lot: JLT-PL 02 08-S/07640178987388/4-8826, 5-4142, 5-5377, 5-0643, 5-2431; JLT-PL 02 10-S/07640178987395/6-5488, 6-6556, 5-0644, 6-4734, 6-4735, 5-5378, 6-3211; JLT-PL 02 12-S/07640178987401/6-5489, 6-6558, 6-7645, 6-8734, 6-4732, 4-8828, 5-5379, 6-4733; JLT-PL 02 14-S/07640178987418/5-8439, 4-8829, 6-0714, 5-5380; JLT-PL 02 16-S/07640178987425/4-8830, 5-4145, 6-3217, 6-0726, 6-5490; JLT-PL 04 08-S/07640178987456/4-8845, 5-4146, 6-0725; JLT-PL 04 10-S/07640178987463/4-8831, 5-4147, 6-0722; JLT-PL 04 12-S/07640178987470/4-8832, 5-4148, 5-8438, 6-0721, 6-3209; JLT-PL 04 14-S/07640178987487/4-3861, 4-8833, 5-4149; JLT-PL 04 16-S/07640178987494/5-4150; JLT-PL 04 18-S/07640178987500/5-4151

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1426-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1426-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-24

Product code OVD

K190877Class IIJuliet® Ti LL Lumbar Interbody DeviceSpineart / cleared 2019-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)