The Recall Desk
HighFDA (Devices)·Z-1758-2024·Announced 2024-05-15

Spinal Fusion Device Recall: Setscrew Insertion and Tightening Issues

SPINEART's PERLA TL 25D spinal fusion screws are being recalled due to difficulties with setscrew insertion inside the screw head. The setscrew may not be properly tightened or may be positioned incorrectly, potentially affecting spinal stability.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product (an implanted spinal fusion device) where mechanical defects affecting structural integrity could impact patient safety. No injuries or hospitalizations have been reported as of the recall announcement, placing this at the High severity level per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

The PERLA TL 25D SCREW system, manufactured by SPINEART SA, is being recalled due to difficulties with setscrew insertion and tightening. The device is intended to provide spinal immobilization and stabilization as an adjunct to fusion surgery for conditions including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumors, and failed previous fusions in skeletally mature patients.

The recall addresses manufacturing issues where the setscrew may either fail to tighten to the required torque specification or become positioned askew during insertion into the screw head. Improper setscrew engagement could compromise the mechanical stability intended by the spinal fusion system.

Approximately 242 affected systems have been distributed nationwide, with devices reaching CA and KY. No injuries or adverse events have been reported as of the recall announcement.

Physicians and patients with implanted devices should contact SPINEART SA and the FDA for information specific to their device model number and lot number, and to determine whether clinical follow-up or corrective action is warranted.

The recalled product

Product
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
Manufacturer
SPINEART SA
Category
Medical Device — Spinal Fusion
Hazard
  • setscrew-defect
  • improper-tightening
  • positioning-error

Distribution

Distributed nationwide across the United States.

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