Medtronic Sofamor Danek recalls Grafton Crunch 5CC and 15CC bone graft products due to potential packaging non-conformances that could breach the sterile barrier. Affected units have specific serial numbers and reference codes listed in the recall.
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 Crunch bone graft products (5CC and 15CC sizes) because their packaging might not meet sterile standards. This could lead to a breach in the sterile barrier, potentially exposing the product to contamination. If you own one of these products, you should check the serial numbers and reference codes listed in the recall.
The packaging system for these products uses a dual-barrier sterile pouch. If the packaging is non-conforming, it could breach the sterile barrier, potentially exposing the product to contamination during use. This is a manufacturing issue that does not involve immediate injury risks.
Patients and medical professionals who use these bone graft products for surgical procedures are most at risk. The recall affects specific units with particular serial numbers and reference codes.
Check if your product has the reference codes S44105, S44115, T44105, or T44115 with the specific serial numbers listed in the recall notice. The products are labeled as 'DBM Grafton Crunch' with 5CC or 15CC sizes.
Look for the reference code (S44105, S44115, T44105, or T44115) and serial numbers listed in the recall notice.
Medtronic Sofamor Danek is recalling certain Grafton Crunch bone graft products (5CC and 15CC sizes) due to potential packaging non-conformances that could breach the sterile barrier.
Check the reference code and serial numbers on your product. Affected units have specific reference codes (S44105, S44115, T44105, or T44115) and serial numbers listed in the recall notice.
The recall does not require immediate action beyond checking if your product is 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-1324-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1324-2023 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.
