Geneva 15, N/A, Switzerland

SPINEART SA recalls

6 recalls recorded since 2018, most recently on 30 June 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.

Recalls6

Ongoing (FDA)3

Terminated or completed3

Class I (FDA)0

Ongoing Class II Medical devices

Recall started: 30 June 2025
Reason: Cannulated fenestrated polyaxial screws may be incorrectly labeled
Distribution: US Nationwide distribution in the states of Florida , Kentucky, California.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2280-2025, Z-2279-2025

Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
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 Compo

Ongoing Class II Medical devices

Recall started: 15 March 2024
Reason: Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tightened to torque but position askew
Distribution: U.S. Nationwide distribution in the states of CA, and KY. Not provided due to affected devices were manufactured O.U.S.
Initiated: Voluntary: Firm initiated
Recall number: Z-1758-2024

PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S T

Ongoing Class II Medical devices

Recall started: 16 March 2023
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.
Distribution: US Nationwide distribution in the states of NH, TX, CA, VA, IL, RI, NC, AZ.
Initiated: Voluntary: Firm initiated
Recall number: Z-1426-2023

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

Terminated Class II Medical devices

Recall started: 9 April 2021
Terminated: 29 September 2022
Reason: Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Distribution: U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided
Initiated: Voluntary: Firm initiated
Recall number: Z-1975-2021

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

Terminated Class III Medical devices

Recall started: 5 February 2019
Terminated: 28 April 2021
Reason: Inner blister pack label is incorrect and does not match the correct external box label.
Distribution: US: CA OUS: Unknowns
Initiated: Voluntary: Firm initiated
Recall number: Z-0546-2020

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

Terminated Class II Medical devices

Recall started: 27 November 2017
Terminated: 27 August 2019
Reason: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
Distribution: US Distribution to the state of : CA
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0337-2018, Z-0341-2018, Z-0336-2018, Z-0342-2018, Z-0339-2018, Z-0338-2018, Z-0340-2018

TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.