LineSider recallZ-0421-2023 · Integrity Implants Inc. · initiated Aug 3, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integrity Implants Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for intraoperative screw head separation at weld location.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0421-2023
- Status
- Terminated
- Initiated by the company
- Aug 3, 2022
- Posted by the FDA
- Dec 5, 2022
- Recalling firm
- Integrity Implants Inc.
- Quantity
- 50 screws
- Product code
- NKB
- FDA submissions
- K203367
- Distribution
- US distribution to California, Indiana, New York, Oklahoma, Washington DC
Product description
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.
Code information (models, lots, serial numbers)
Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
Product lines
Other devices under the same FDA submission
68 devices cleared under K203367 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6MG7545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall2 reports
- LineSider LS-N6SG6550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall1 report
- LineSider LS-N6SG7545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall1 report
- LineSider LS-N6SG5535Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG5540Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG5545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG5550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG5555Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG6535Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG6540Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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