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, J

FDA device recall Z-1426-2023 · posted 2023-04-24 · Open, Classified

Recall details

Recalling firm

SPINEART SA

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.

Action taken

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

Root cause

Process change control

Status

Open, Classified

Product code

OVD

Quantity affected

544

Distribution

US Nationwide distribution in the states of NH, TX, CA, VA, IL, RI, NC, AZ.

Date initiated

2023-03-16

Date posted

2023-04-24

Location

Plan-Les-Ouates, Switzerland

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