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 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-

Hazard

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

Details from the source

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. Quantity: 242 systems Lot/code info: 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

UPC codes

07640185345799, 07640185345805, 07640185345812, 07640185345829, 07640185345836, 07640185345850, 07640185345867, 07640185345874, 07640185345881, 07640305166082

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.