Home / Recalls / SPINEART SA / Z-0546-2020

Z-0546-2020 Class III Terminated

Recalled by SPINEART SA — Plan-Les-Ouates

Recall Details

Product Type
Devices
Report Date
December 4, 2019
Initiation Date
February 5, 2019
Termination Date
April 28, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14 pieces distribtued to 1 US Distributor

Product Description

Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures

Reason for Recall

Inner blister pack label is incorrect and does not match the correct external box label.

Distribution Pattern

US: CA OUS: Unknowns

Code Information

Model Number: JUT-OX 28 09-S Lot Number: 4-2899 UDI: (01) 0 7640178 97398 5 (11) 181102 (17) 261101 (10) 4-2899

Other recalls by SPINEART SA

  • Z-2280-2025 Class II — Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW (June 30, 2025)
  • Z-2279-2025 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-1426-2023 Class II — JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 (March 16, 2023)
  • Z-1975-2021 Class II — PERLA TL Lateral Connector Open - Product Usage: intended to be used with autogr (April 9, 2021)
  • 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)