Z-1426-2023 Class II Ongoing
FDA device recall Z-1426-2023 was initiated by SPINEART SA on March 16, 2023 and is designated Class II. 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 ho… The recall status is ongoing. Affected quantity: 544.
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2023
- Initiation Date
- March 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 544
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of NH, TX, CA, VA, IL, RI, NC, AZ.
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