Integrity Implants recalls LineSider Spinal System screws for 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 certain LineSider Spinal System screws due to a risk that the Upper Tulip Head could separate from the Lower Tulip Head, potentially causing the screw to fail during spinal surgery. This is a serious hazard for patients who have received these screws.
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, which could lead to failure during spinal surgery.
Patients who received the recalled LineSider Spinal System screws during surgery are most at risk. The product is used in spinal fixation procedures and sold to medical facilities.
Check the product label for sizes like 5.5mm x 35mm to 8.5mm x 60mm. Look for specific part numbers starting with LS-N6SG and lot numbers from 2210139 to 2210161.
Immediately stop using the recalled LineSider Spinal System screws if you have them.
The hazard is potential weld separation between the Upper Tulip Head and Lower Tulip Head components, which could cause the Tulip Head to separate from the screw shank during spinal surgery.
Affected sizes include 5.5mm x 35mm to 8.5mm x 60mm. Lot numbers range from 2210139 to 2210161.
Check the product label for part numbers starting with LS-N6SG and lot numbers from 2210139 to 2210161.
We’ve drafted a message you can send Integrity Implants to request your refund or repair — edit it as you like.
Subject: Recall Z-0419-2023 — Integrity Implants Integrity Implants Hello, I own a Integrity Implants that is covered by recall Z-0419-2023 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.
