Medtronic Sofamor Danek USA recalls Grafton Plus Paste products with specific serial numbers due to potential packaging non-conformances that could breach the sterile barrier. Affected items may not be safe for medical use.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Medtronic Sofamor Danek is recalling specific Grafton Plus Paste products because their packaging might not be sterile, which could lead to contamination. This is a safety issue for medical use.
The packaging system for these medical products may have defects that could breach the sterile barrier, potentially exposing the product to contaminants. This is a manufacturing issue with the packaging, not the product itself.
Patients using these specific Grafton Plus Paste products for medical procedures are at risk of contamination. The recall affects only the listed serial numbers and product variants.
Check your Grafton Plus Paste product for the model numbers (1CC, 5CC, or 10CC) and the specific serial numbers listed in the recall notice. The affected items have unique serial numbers starting with A40000- or similar patterns.
Identify your Grafton Plus Paste product by model (1CC, 5CC, or 10CC) and serial number from the list provided in the recall notice.
If your product is listed, contact Medtronic Sofamor Danek USA directly for further instructions.
The packaging may not be sterile, which could lead to contamination during medical procedures. This is a manufacturing issue with the packaging system.
Check the serial number on your product against the list of affected serial numbers provided in the recall notice.
The recall does not specify a return process; contact Medtronic Sofamor Danek USA directly for instructions if your product is affected.
We’ve drafted a message you can send Medtronic Sofamor Danek to request your refund or repair — edit it as you like.
Subject: Recall Z-1329-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1329-2023 from Medtronic Sofamor Danek. 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.
