Integrity Implants LineSider Spinal Screws Recall: Risk of Screw Separation During Surgery
Integrity Implants recalls LineSider Spinal System pedicle screws due to potential for screw head separation during surgery. Affected models include LS-N6SG6545. Consumers should contact the company for details.
Recall notice
Potential for intraoperative screw head separation at weld location.
Contact the company
What happened, in plain English
Integrity Implants is recalling certain spinal screws used in surgery because they might separate during the procedure. This could lead to complications for patients needing spinal surgery. Read more at govinfonow.com/recall/60218-integrity-implants-linesider-spinal-screws-recall-risk-of-screw-separation.
Source Summary by GovInfoNow · govinfonow.com/recall/60218-integrity-implants-linesider-spinal-screws-recall-risk-of-screw-separation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0421-2023
Cite this page
“Integrity Implants LineSider Spinal Screws Recall: Risk of Screw Separation During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60218-integrity-implants-linesider-spinal-screws-recall-risk-of-screw-separation. Based on FDA recall #Z-0421-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0421-2023%22&limit=1).
Why it’s dangerous
The screws have a potential risk of the screw head separating at the weld location during surgery. This could cause complications for patients needing spinal fixation.
Who’s affected
Patients who have received these specific spinal screws during surgery are affected. Surgeons and medical facilities using the recalled model are at highest risk.
How to tell if you have this one
Check for the model number LS-N6SG6545 on the screw packaging or surgical tray. The product was sold as non-sterile and shipped in protective sterilization trays.
- Brand
Integrity Implants- Product
LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number- Category
Medical device
What to do — step by step
Contact Manufacturer
Reach out to Integrity Implants for specific guidance on the recalled screws and next steps.
Where it went and when
Where it was distributed
Distributed in 4 states and D.C..
FDA distribution: “US distribution to California, Indiana, New York, Oklahoma, Washington DC” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, District of Columbia, Indiana, New York, Oklahoma.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0421-2023 (August 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0421-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.