Medtronic Sofamor Danek recalls specific Grafton DBM Putty models due to potential non-conformances in the outer Tyvek pouch 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 specific models of Grafton DBM Putty because the outer Tyvek pouch might not have been inspected correctly during production. This could mean the pouch doesn't meet safety standards, though the risk of harm isn't described as serious.
The recall is because the outer Tyvek pouch might not have been inspected properly during manufacturing. This could lead to non-conforming pouches that don't meet safety standards, though the specific risk isn't described as causing serious injury.
People who own or use the recalled Grafton DBM Putty models (T43102, T43102INT, T43103INT, T43105, T43105INT, T43110, T43110INT) are affected. Those using the product for medical purposes may be at slightly higher risk due to potential pouch issues.
Check the product label for model numbers: T43102, T43102INT, T43103INT, T43105, T43105INT, T43110, or T43110INT. The product is a demineralized bone matrix used in medical applications.
Look for model numbers on the label: T43102, T43102INT, T43103INT, T43105, T43105INT, T43110, or T43110INT.
The recall is because the outer Tyvek pouch might not have been inspected correctly during manufacturing, which could lead to non-conforming pouches that don't meet safety standards.
The affected models are T43102, T43102INT, T43103INT, T43105, T43105INT, T43110, and T43110INT.
The recall record does not mention any remedy or action steps for the affected products.
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-0167-2024 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-0167-2024 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.
