Home / Recalls / SPINEART SA / Z-2279-2025

Z-2279-2025 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
August 20, 2025
Initiation Date
June 30, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16 units

Product Description

Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No

Reason for Recall

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Distribution Pattern

US Nationwide distribution in the states of Florida , Kentucky, California.

Code Information

Lot Code: Lot number 8-4528 GTIN 07640305160561

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-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-0546-2020 Class III — Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures (February 5, 2019)
  • 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)
  • Z-0336-2018 Class II — TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY- (November 27, 2017)