Home / Recalls / SPINEART SA / Z-1426-2023

Z-1426-2023 Class II Ongoing

Recalled by SPINEART SA — Plan-Les-Ouates, N/A

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

Other recalls by SPINEART SA

  • Z-2279-2025 Class II — Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW (June 30, 2025)
  • Z-2280-2025 Class II — Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW (June 30, 2025)
  • Z-1758-2024 Class II — PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-D (March 15, 2024)
  • Z-1975-2021 Class II — PERLA TL Lateral Connector Open - Product Usage: intended to be used with autogr (April 9, 2021)
  • Z-0546-2020 Class III — Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures (February 5, 2019)
  • Z-0340-2018 Class II — TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY- (November 27, 2017)
  • Z-0339-2018 Class II — TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY (November 27, 2017)
  • Z-0338-2018 Class II — TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY- (November 27, 2017)
  • Z-0341-2018 Class II — TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY- (November 27, 2017)
  • Z-0342-2018 Class II — TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY- (November 27, 2017)