Medtronic Sofamor Danek recalls Grafton DBF Inject 3CC and 6CC products with potential packaging non-conformances that could breach the sterile barrier. Affected items have specific 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 Inject products (3CC and 6CC) due to potential packaging issues that could breach the sterile barrier. This means the products might not be sterile when used, which could lead to infection risks.
The packaging system for these products is designed to be sterile. If the packaging has non-conformances, it could breach the sterile barrier, potentially allowing contamination of the product. This might lead to infection if the product is used without proper sterility.
Patients using these specific Grafton DBF Inject products for bone grafts are affected. The risk is low because the packaging issue is unlikely to cause serious injury in normal use.
Check if your product has the model numbers GRAFTON T50303 DBF INJECT 3CC or GRAFTON T50306 DBF INJECT 6CC with the serial numbers listed in the recall notice. The products are used for bone grafts in medical procedures.
Verify your product's model number and serial numbers against the list provided in the recall notice to confirm if it's affected.
Medtronic Sofamor Danek is recalling Grafton DBF Inject 3CC and 6CC products with specific serial numbers listed in the recall notice.
The packaging may have non-conformances that could breach the sterile barrier, potentially leading to contamination if the product is used without proper sterility.
Check your product's model number and serial numbers 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-1331-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1331-2023 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.
