Device 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
Z-1426-2023
Product summary
- Firm
- SPINEART SA
- Event
- Event 91973
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 544
- Official record key
device-enforcement:Z-1426-2023
Official wording
Reason: 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.
Code information: 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
Distribution pattern: US Nationwide distribution in the states of NH, TX, CA, VA, IL, RI, NC, AZ.
Derived failure modes
-
Unknown
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.