Integrity Implants recalls LineSider Spinal System screws due to potential weld separation between Tulip Head components, which could cause 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 certain LineSider Spinal System screws because they might separate during surgery, leading to potential failure. This is a critical issue for patients who have received these screws in spinal procedures.
The screws have a potential risk of 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, which might cause the spinal fixation to fail during surgery.
Patients who received the recalled LineSider Spinal System screws during spinal surgery are most at risk. The product is used in spinal fixation procedures and sold to medical facilities.
Check if your LineSider Spinal System screws have the following sizes: 5.5mm x 35mm to 9.5mm x 55mm. Look for specific part numbers and lot numbers listed in the recall notice.
Reach out to Integrity Implants directly to confirm if your specific screw model and lot number are affected.
The recall indicates a potential risk of weld separation, so affected units should not be used in surgery. Patients should contact the manufacturer for verification.
Contact Integrity Implants to determine if your specific screw model and lot number are affected. They will guide you on next steps.
Check the part numbers and lot numbers listed in the recall notice for the specific sizes of LineSider Spinal System screws you have.
We’ve drafted a message you can send Integrity Implants to request your refund or repair — edit it as you like.
Subject: Recall Z-0420-2023 — Integrity Implants Integrity Implants Hello, I own a Integrity Implants that is covered by recall Z-0420-2023 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.
