Medtronic Sofamor Danek recalls specific Grafton DMB Matrix products (model T42200/T42210) due to potential non-conformances in the outer Tyvek pouch 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 Grafton DMB Matrix products (model numbers T42200 and T42210) because some units may have improper inspection of the outer Tyvek pouch during production. This could lead to pouch defects that might affect the product's safety.
The recall is due to potential non-conformances in the outer Tyvek pouch during manufacturing. If the pouch inspection step was not performed correctly, the product may have defects that could affect its safety and effectiveness.
Patients using the Grafton DMB Matrix for bone grafts are likely affected. Those with specific serial numbers listed in the recall notice are at risk of pouch defects.
Check if your Grafton DMB Matrix product has model numbers T42200 or T42210 with the specific serial numbers listed in the recall notice. The product is a demineralized bone matrix used in bone graft procedures.
Verify if your product has model numbers T42200 or T42210 with the specific serial numbers listed in the recall notice.
Medtronic Sofamor Danek is recalling specific Graft: Grafton DMB Matrix products (model numbers T42200 and T42210) due to potential non-conformances in the outer Tyvek pouch during manufacturing.
Check if your product has model numbers T42200 or T42210 with 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-0163-2024 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-0163-2024 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.
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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.
