Recall Z-1426-2023 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
SPINEART SA
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
| Date | Apr 24, 2023 (initiated Mar 16, 2023) |
| Status | Open, Classified |
| 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. |
| 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 |
| Quantity | 544 |
| Distribution | US Nationwide distribution in the states of NH, TX, CA, VA, IL, RI, NC, AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190877 | Juliet® Ti LL Lumbar Interbody Device Spineart, May 29, 2019 |