Medtronic Sofamor Danek recalls specific Grafton Matrix Strips due to potential packaging non-conformances that could breach the sterile barrier. Affected items have unique model numbers and serials listed in the recall notice.
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 certain Grafton Matrix Strips products because their packaging might not meet sterile standards, which could lead to a breach in the sterile barrier. This means the products might not be safe for medical use without proper sterilization.
The packaging uses a dual-barrier sterile pouch system that may have non-conforming elements. If the packaging is compromised, it could lead to a breach in the sterile barrier, potentially exposing the product to contaminants.
Patients using these specific Grafton Matrix Strips products for medical procedures are most at risk if the packaging is compromised. The recall affects a limited number of units with specific model numbers and serials.
Check for model numbers like DBM S42275, DBM S42280, or DBM T42275 with specific dimensions (8mm x 1cm x 10cm or 20cm) and serial numbers listed in the recall notice.
Look for model numbers (DBM S42275, DBM S42280, DBM T42275) and serial numbers listed in the recall notice to confirm if your product is affected.
Medtronic Sofamor Danek is recalling specific Grafton Matrix Strips products due to potential packaging non-conformances that could breach the sterile barrier.
Check for model numbers like DBM S42275, DBM S42280, or DBM T42275 with specific dimensions (8mm x 1cm x 10cm or 20cm) and serial numbers listed in the recall notice.
The recall does not require immediate action; you only need to check if your product is affected using the model and serial numbers provided in the recall notice.
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-1328-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1328-2023 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.
