Recall Z-1758-2024 · NKB Thoracolumbosacral Pedicle Screw System
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-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 follow
| Date | May 3, 2024 (initiated Mar 15, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Process design |
| Action | 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 us |
| Quantity | 242 systems |
| Distribution | U.S. Nationwide distribution in the states of CA, and KY. Not provided due to affected devices were manufactured O.U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193396 | PERLA® TL posterior osteosynthesis system Spineart, Feb 5, 2020 |