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...
FDA Device Recall #Z-1758-2024 — Class II — March 15, 2024
Recall Summary
| Recall Number | Z-1758-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 15, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | SPINEART SA |
| Location | Plan-Les-Ouates, N/A |
| Product Type | Devices |
| Quantity | 242 systems |
Product Description
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 TLF-DS 65 50-S The PERLA¿ TL system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (painful degeneration of the disc), spondylolisthesis, trauma, spinal stenosis, deformities (i.e. scoliosis, kyphosis, or lordosis), tumor and failed previous fusion (pseudarthrosis).
Reason for Recall
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 Pattern
U.S. Nationwide distribution in the states of CA, and KY. Not provided due to affected devices were manufactured O.U.S.
Lot / Code Information
Model Numbers/Lot-Batch Numbers: TLF-DS 45 25-S 7-4407 TLF-DS 45 25-S 7-6207 TLF-DS 45 30-S 7-4244 TLF-DS 45 30-S 7-6226 TLF-DS 45 35-S 7-4242 TLF-DS 45 35-S 7-5470 TLF-DS 45 35-S 7-6684 TLF-DS 45 40-S 7-6232 TLF-DS 45 45-S 7-5474 TLF-DS 45 45-S 7-6874 TLF-DS 55 30-S 7-4409 TLF-DS 55 30-S 7-4695 TLF-DS 55 30-S 7-4965 TLF-DS 55 35-S 7-4413 TLF-DS 55 35-S 7-6455 TLF-DS 55 40-S 7-4415 TLF-DS 55 40-S 7-4417 TLF-DS 55 45-S 7-4411 TLF-DS 55 45-S 7-5055 TLF-DS 55 45-S 7-6087 TLF-DS 55 45-S 7-6459 TLF-DS 65 35-S 7-4405 TLF-DS 65 35-S 7-6230 TLF-DS 65 35-S 7-6461 TLF-DS 65 35-S 7-6882 TLF-DS 65 40-S 7-4248 TLF-DS 65 40-S 7-4250 TLF-DS 65 40-S 7-5480 TLF-DS 65 40-S 7-6228 TLF-DS 65 40-S 7-6554 TLF-DS 65 40-S 7-6740 TLF-DS 65 45-S 7-4582 TLF-DS 65 45-S 7-5484 TLF-DS 65 45-S 7-5808 TLF-DS 65 45-S 7-6668 TLF-DS 65 45-S 7-6742 TLF-DS 65 45-S 7-7299 TLF-DS 65 50-S 7-5488 TLF-DS 65 50-S 7-9264 UDI-DI for associated Model Numbers: TLF-DS 45 25-S 07640185345799 TLF-DS 45 30-S 07640185345805 TLF-DS 45 35-S 07640185345812 TLF-DS 45 40-S 07640185345829 TLF-DS 45 45-S 07640185345836 TLF-DS 55 30-S 07640185345850 TLF-DS 55 35-S 07640185345867 TLF-DS 55 40-S 07640185345874 TLF-DS 55 45-S 07640185345881 TLF-DS 60 35-S 07640305166082
Other Recalls from SPINEART SA
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2279-2025 | Class II | Brand Name: PERLA ¿ TL MIS Product Name: CANNU... | Jun 30, 2025 |
| Z-2280-2025 | Class II | Brand Name: PERLA ¿ TL MIS Product Name: CANNU... | Jun 30, 2025 |
| Z-1426-2023 | Class II | JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMAL... | Mar 16, 2023 |
| Z-1975-2021 | Class II | PERLA TL Lateral Connector Open - Product Usage... | Apr 9, 2021 |
| Z-0546-2020 | Class III | Intersomatic JULIET Ti OL cage. For use in orth... | Feb 5, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.