PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S… — Class II medical device recall Z-1758-2024
Ongoing recall by SPINEART SA, reported 2024-05-15, distributed nationwide. Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issu
| Recall number | Z-1758-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SPINEART SA, Plan-Les-Ouates, N/A, Switzerland |
| Recall initiated | 2024-03-15 |
| Classified | 2024-05-03 |
| Reported by FDA | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 242 systems |
| UPC / GTIN / UDI-DI | 07640185345799, 07640185345805, 07640185345812, 07640185345829, 07640185345836, 07640185345850, 07640185345867, 07640185345874, 07640185345881, 07640305166082 |
| Lot numbers | 25-S, 30-S, 35-S, 40-S, 45-S, 50-S, 7-4242, 7-4244, 7-4248, 7-4250, 7-4405, 7-4407, 7-4409, 7-4411, 7-4413, 7-4415, 7-4417, 7-4582, 7-4695, 7-4965, 7-5055, 7-5470, 7-5474, 7-5480, 7-5484, 7-5488, 7-5808, 7-6087, 7-6207, 7-6226, 7-6228, 7-6230, 7-6232, 7-6455, 7-6459, 7-6461, 7-6554, 7-6668, 7-6684, 7-6740 and 5 more |
| Model numbers | 07640185345799, 07640185345805, 07640185345812, 07640185345829, 07640185345836, 07640185345850, 07640185345867, 07640185345874, 07640185345881, 07640305166082, 25-S, 30-S, 35-S, 40-S, 45-S, 50-S |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1758-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.