Integrity Implants recalls certain LineSider Spinal System screws due to potential weld separation between components, which could lead to failure during spinal surgery. Affected units include specific sizes and lot numbers.
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Integrity Implants is recalling specific spinal screws that may separate during surgery, risking improper spinal fixation. This is a serious hazard for patients undergoing spinal surgery with these components.
The screws have a potential for weld separation between the Upper Tulip Head and Lower Tulip Head components. If this separation occurs, the Tulip Head could detach from the Screw Shank, compromising spinal stability during surgery.
Patients who received the recalled LineSider Spinal System screws during surgery are most at risk. Medical professionals using these screws in procedures are also affected.
Check the product label for sizes like 5.5mm x 35mm to 8.5mm x 60mm. Look for specific part numbers (e.g., LS-N6SA5535) and lot numbers (e.g., 2210117) on the packaging or sterilization tray.
Reach out to Integrity Implants directly for guidance on whether your specific screw model is affected and what to do next.
The recall states there is a potential for weld separation that could lead to failure during spinal surgery, but it does not specify if this has caused injuries.
Check the product label for specific sizes and part numbers listed in the recall, such as 5.5mm x 35mm with part number LS-N6SA5535 or lot number 2210117.
The recall does not provide a remedy, so there is no instruction to stop using or discard the screws. Patients should contact the manufacturer for specific guidance.
We’ve drafted a message you can send Integrity Implants to request your refund or repair — edit it as you like.
Subject: Recall Z-0418-2023 — Integrity Implants Integrity Implants Hello, I own a Integrity Implants that is covered by recall Z-0418-2023 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.
