Medtronic Sofamor Danek recalls specific Grafton Matrix products due to potential packaging non-conformances that could breach the sterile barrier. Affected items have unique 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 Matrix products because their packaging might not meet sterile requirements, which could lead to a breach in the sterile barrier. This recall affects specific product models with unique serial numbers.
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 the Grafton Matrix products for bone grafts are most at risk if the packaging is compromised. The recall affects specific product models with unique serial numbers listed in the recall notice.
Check for the product model codes (DBM S42200, S42210, T42200, etc.) and serial numbers listed in the recall notice. The products are sold in specific sizes (2.5cm x 5cm or 2.5cm x 10cm) with two units per package.
Look for the model codes (DBM S42200, S42210, T42200, etc.) and serial numbers listed in the recall notice to confirm if your product is affected.
Medtronic Sofamor Danek is recalling specific Grafton Matrix products due to potential packaging non-conformances that could breach the sterile barrier.
Check for the model codes (DBM S42200, S42210, T42200, etc.) and serial numbers listed in the recall notice. The products are sold in specific sizes (2.5cm x 5cm or 2.5cm x 10cm) with two units per package.
The recall notice lists specific serial numbers for affected products. Check your product details against the list to determine if it's affected.
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-1327-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1327-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
