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Class 2 Device Recall JULIET Lateral Lumbar TiLife Plate |
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| Date Initiated by Firm |
March 16, 2023 |
| Date Posted |
April 24, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1426-2023 |
| Recall Event ID |
91973 |
| 510(K)Number |
K190877
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| Product Classification |
Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
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| 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 |
| 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 |
Recalling Firm/
Manufacturer |
SPINEART SA
Chemin Du Pre-Fleuri 3
Plan-Les-Ouates Switzerland
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Manufacturer 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.
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FDA Determined
Cause 2 |
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 orders@spineart.us
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 orders@spineart.us |
| Quantity in Commerce |
544 |
| Distribution |
US Nationwide distribution in the states of NH, TX, CA, VA, IL, RI, NC, AZ. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database |
510(K)s with Product Code = OVD and Original Applicant = SPINEART
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