# FDA recall Z-1758-2024

> **SPINEART SA** · Class II · device recall initiated 2024-03-15.

## 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 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

U.S. Nationwide distribution in the states of CA, and KY. Not provided due to affected devices were manufactured O.U.S.

## Key facts

- **Recall number:** Z-1758-2024
- **Recalling firm:** SPINEART SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-15
- **Report date:** 2024-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plan-Les-Ouates, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1758-2024

## Citation

> AI Analytics. FDA recall Z-1758-2024. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1758-2024. Source: US FDA. Licensed CC0.

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