Medtronic Sofamor Danek recalls Grafton Gel products with specific serial numbers due to potential packaging non-conformances that could breach the sterile barrier.
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 several Grafton Gel 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 Grafton Gels uses a dual-barrier sterile pouch that may have non-conforming elements. If the packaging is breached, the product could become contaminated, posing a risk of infection during medical procedures.
Patients using Grafton Gel for medical procedures are most at risk if the packaging is compromised. The recall affects specific product models and serial numbers.
Check your Grafton Gel product for the model codes (S41120, S41150, T41110, etc.) and serial numbers listed in the recall notice. The products are used in medical procedures and have specific GTINs and serial number ranges.
Identify your Grafton Gel product by model code (e.g., S41120, S41150) and serial numbers listed in the recall notice.
Medtronic Sofamor Danek is recalling Grafton Gel products with specific model codes and serial numbers due to potential packaging non-conformances that could breach the sterile barrier.
Check your product's model code (e.g., S41120, S41150) and serial numbers against the list provided in the recall notice.
The recall does not specify a remedy, so you should contact Medtronic Sofamor Danek directly for guidance on next steps.
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-1333-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1333-2023 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.
