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).

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

On 03/15/2024, the firm called and then emailed one distributor, Spineart USA, Inc.(U.S. Distribution Center) to quarantine products in stock and identify locations of products already distributed. the firm's U.S. Distribution Center sent an "URGENT: MEDICAL DEVICE RECALL" letter on 04/08/2024 via email to customers to inform them that Customers have been instructed as follow: 1. Immediately review your inventory and quarantine concerned products if any. 2. You may have further distributed this product; please identify concerned customers and notify them at once of this product recall by using this document. 3. Collect and quarantine all products. 4. Sent back all products with the enclosed Response Form to Spineart warehouse SPINEART SLI, ATTN LAURE-ALLISON VERBOUX, 80 RUE DOUGLAS ENGELBART FR-74160 ST JULIEN EN GENEVOIS E-mail: [email protected]