Recall Z-0421-2023 · NKB Thoracolumbosacral Pedicle Screw System
Integrity Implants Inc.
LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Used in spinal fixation surgery.
| Date | Dec 5, 2022 (initiated Aug 3, 2022) |
| Status | Terminated |
| Reason | Potential for intraoperative screw head separation at weld location. |
| Root cause | Under Investigation by firm |
| Action | Integrity Implants notified consignees on about 08/03/2022 via emailed letter. The letter instructed consignees to examine inventory and quarantine any affected product, arrange for the return of affected products, and complete and return the response form. |
| Quantity | 50 screws |
| Distribution | US distribution to California, Indiana, New York, Oklahoma, Washington DC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203367 | LineSider™ Spinal System Integrity Implants, Inc., Dec 3, 2020 |