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.
Hazard
Potential for intraoperative screw head separation at weld location.
What You Should Do
Remedy
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.
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Products
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
- Brand
- Integrity Implants Inc.
- UPC
- Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067
Units Affected
50 screws