High FDA (Devices)·Z-1426-2023·Announced 2023-05-03

Lateral lumbar spine implant plate may disassemble during surgery

SPINEART's JULIET Ti LL lateral lumbar implant plates may disassemble during preparation or implant removal, causing surgical delays. The FDA is recalling 544 affected units distributed across eight US states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with identified risk of surgical complication (disassembly during implantation or removal). No illnesses or injuries have been reported, but the potential for device failure during a critical surgical procedure places this at the risk-of-harm threshold.

Plain-English summary

SPINEART SA is recalling JULIET Ti LL lateral lumbar Ti-Life plates, components used in lumbar spinal fusion surgery. These implant plates are designed to stabilize and fuse vertebrae in the lower spine.

The plates may disassemble during the preparation stage before implantation or during surgery when the surgeon removes the implant holder. This disassembly can cause surgical delays and may prevent proper implant placement during the procedure.

The recall affects 544 units distributed across the United States, with documented distribution in New Hampshire, Texas, California, Virginia, Illinois, Rhode Island, North Carolina, and Arizona. Specific lot numbers and reference codes have been identified in FDA records.

Surgeons and hospitals that received these implants should review affected lot numbers and consider alternative implants for upcoming procedures. Healthcare providers should contact SPINEART or the FDA for guidance on managing inventory and patient care.

The recalled product

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
Manufacturer: SPINEART SA
Category: Medical Device — Spinal Implant
Hazard: device-disassembly
surgical-delay
Affected units: 544

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Same manufacturer · SPINEART SA

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