Medtronic Sofamor Danek recalls specific Grafton DBM Crunch products with potential Tyvek pouch defects from improper inspection during manufacturing.
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Medtronic Sofamor Danek is recalling certain Grafton DBM Crunch products due to possible defects in the outer Tyvek pouch from incomplete inspection during manufacturing. This could lead to improper product function during medical use.
The hazard involves potential non-conformances in the outer Tyvek pouch due to incomplete inspection steps during manufacturing. This could affect the product's integrity and safety during medical procedures.
Patients using the recalled Grafton DBM Crunch products for bone grafts. Medical professionals handling these products are most at risk if they use the defective items.
Check for model number T44115 and specific serial numbers listed in the recall notice. The product is Demineralized Bone Matrix used in bone graft procedures.
Verify the model number and serial numbers against the list provided in the recall notice to confirm if your product is affected.
The recalled product is Grafton DBM Crunch with model number T44115 and specific serial numbers listed in the recall notice.
Check if your product has model number T44115 and one of the specific serial numbers listed in the recall notice.
The recall notice does not specify a remedy, so contact Medtronic Sofamor Danek directly for guidance.
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-0161-2024 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-0161-2024 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.
