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.
Potential for intraoperative screw head separation at weld location.
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.
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.
Patients who have received these specific spinal screws during surgery are affected. Surgeons and medical facilities using the recalled model are at highest risk.
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.
Reach out to Integrity Implants for specific guidance on the recalled screws and next steps.
The recall indicates a potential risk of screw head separation during surgery, so they are not considered safe without the recall fix.
Check for the model number LS-N6SG6545 on the screw packaging or surgical tray.
Contact Integrity Implants directly for specific instructions on the recalled screws.
We’ve drafted a message you can send Integrity Implants to request your refund or repair — edit it as you like.
Subject: Recall Z-0421-2023 — Integrity Implants Integrity Implants Hello, I own a Integrity Implants that is covered by recall Z-0421-2023 from Integrity Implants. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
