CLASS II Device recall · Reported 14 Dec 2022 · FDA Enforcement Report
LineSider Spinal System pedicle screws, Non-mod Standard recalled
Integrity Implants is recalling LineSider Spinal System pedicle screws, Non-mod Standard - Dual Lead, Non-cannulated, distributed in California, District of Columbia, Indiana, New York, Oklahoma. The recall was initiated on 3 Aug 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0421-2023
- FDA event ID
- 91071
- Recalling firm
- Integrity Implants, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Aug 2022
- FDA classified
- 5 Dec 2022
- Reported
- 14 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 3 Aug 2022 | Recall initiated by company | |
| 5 Dec 2022 | Classified by FDA | +124 days |
| 14 Dec 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for intraoperative screw head separation at weld location.
Product as listed by the FDA
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.
Where it was distributed
US distribution to California, Indiana, New York, Oklahoma, Washington DC
Questions about this recall
Why was it recalled?
Potential for intraoperative screw head separation at weld location.
Which lots are affected?
Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067
Where was it sold?
US distribution to California, Indiana, New York, Oklahoma, Washington DC
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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