Home / Recalls / SPINEART SA / Z-1975-2021

Z-1975-2021 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
July 7, 2021
Initiation Date
April 9, 2021
Termination Date
September 29, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44 units in the U.S.

Product Description

PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm

Reason for Recall

Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.

Distribution Pattern

U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided

Code Information

Reference Number/Product Description/Batch Number: -TLF-LC OP 15-S / PERLA TL Lateral Connector Open, 15mm / 5-2983 -TLF-LC OP 30-S / PERLA TL Lateral Connector Open, 30mm / 5-2993

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-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-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)