Medical DeviceAug 20, 2025
PERLA ¿ TL MIS CANNULATED FENESTRATED POLYAXIAL SCREW recall — FDA Z-2280-2025
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Class IIFDA: OngoingSPINEART SA
Recall history in this database
Classification mix: Class II: 3.
Medical DeviceAug 20, 2025
PERLA ¿ TL MIS CANNULATED FENESTRATED POLYAXIAL SCREW recall — FDA Z-2279-2025
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Class IIFDA: OngoingSPINEART SA
Medical DeviceMay 15, 2024
SPINEART SA PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 recall — FDA Z-1758-2024
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…
Class IIFDA: OngoingSPINEART SA
Understanding this recall history
This page summarizes recall records in which the official source identifies SPINEART SA as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.