FDA Recall Open, Classified

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

Recall: Z-1426-2023 · Initiated March 16, 2023

Recall

Recall Number: Z-1426-2023
Event Number: 91973
Firm: SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland
FEI Number: 3007728266
Product Code: OVD
Status: Open, Classified
Root Cause: Process change control
Initiated: March 16, 2023
Posted: April 24, 2023

Description

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.

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 [email protected] 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 [email protected]

Distribution

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

Quantity

544