Z-1758-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2024
- Initiation Date
- March 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 242 systems
Product Description
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 Pattern
U.S. Nationwide distribution in the states of CA, and KY. Not provided due to affected devices were manufactured O.U.S.
Code Information
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