Medtronic Sofamor Danek recalls specific Grafton Flex bone graft products due to potential packaging non-conformances that could breach the sterile barrier. Affected items have specific model numbers and serial numbers 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 Flex bone graft products because their packaging might not meet sterile standards, which could lead to a breach in the sterile barrier. This recall affects specific model numbers and serial numbers listed in the notice.
The packaging system for these products uses a dual-barrier sterile pouch that may not conform properly. If the packaging is non-conforming, it could lead to a breach in the sterile barrier, potentially exposing the product to contamination.
Patients who own or use the recalled Grafton Flex bone graft products are most at risk. The recall affects specific model numbers and serial numbers listed in the notice.
Check the product model numbers and serial numbers listed in the recall notice. The affected products include specific Grafton Flex bone graft items with model numbers like DBM S42090, DBM T42090, and others, along with their associated serial numbers.
Review the model numbers and serial numbers listed in the recall notice to determine if your product is affected.
Medtronic Sofamor Danek is recalling specific Grafton Flex bone graft products due to potential packaging non-conformances that could breach the sterile barrier.
Check the model numbers and serial numbers listed in the recall notice. Affected products include specific Grafton Flex bone graft items with model numbers like DBM S42090, DBM T42090, and others, along with their associated serial numbers.
Check the product details to confirm if it's affected. If it is, you should contact Medtronic Sofamor Danek for further instructions.
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-1325-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1325-2023 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.
