Medtronic Sofamor Danek recalls specific Grafton DBF products due to potential packaging non-conformances that could breach the sterile barrier. Affected items include PUTTY T50101, T50101INT, T50103, T50103INT, T50106, T50106INT models with 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 DBF products because their packaging may not meet sterile requirements, potentially leading to breaches in the sterile barrier. This could affect medical procedures requiring aseptic conditions.
The packaging system for these products is designed to maintain sterility during medical procedures. If the packaging has non-conforming features, it could breach the sterile barrier, potentially exposing the product to contamination.
Patients and medical professionals using the Grafton DBF products for bone grafts are most at risk if the packaging is compromised. The recall affects specific product models with serial numbers listed in the notice.
Check for the product model codes PUTTY T50101, T50101INT, T50103, T50103INT, T50106, or T50106INT with the serial numbers listed in the recall notice.
Identify your product model and serial number to confirm if it's affected by this recall.
The recall affects Medtronic Sofamor Danek Grafton DBF products with model codes PUTTY T50101, T50101INT, T50103, T50103INT, T50106, or T50106INT, and specific serial numbers listed in the recall notice.
If your product model and serial number are not listed in the recall notice, it is not affected by this recall.
Check the product model code and serial number against the list of affected items 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-1330-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1330-2023 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.
