Medtronic Sofamor Danek recalls specific Grafton Plus DBM Paste models (T45001, T45005, T45010) due to potential non-conformances in the outer Tyvek pouch from inspection steps.
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 batches of Grafton Plus DBM Paste (models T45001, T45005, T45010) because the outer Tyvek pouch might not have been inspected properly during manufacturing. This could lead to pouch issues that might affect the product's safety.
The recall is due to potential non-conformances in the outer Tyvek pouch that could result from a step during manufacturing inspection not being performed correctly. This might lead to pouch issues that could affect the product's safety during use.
Patients using bone graft products for spinal fusion or joint repair who own the recalled Grafton Plus DBM Paste models (T45001, T45005, T45010) with specific serial numbers listed in the recall.
Check the product model number (T45001, T45005, or T45010) and the serial numbers listed in the recall notice. The product is Demineralized Bone Matrix paste used in spinal fusion procedures.
Verify the product model number (T45001, T45005, or T45010) and serial numbers against the list provided in the recall notice.
Grafton Plus DBM Paste (models T45001, T45005, T45010) used in spinal fusion procedures.
Due to potential non-conformances in the outer Tyvek pouch from a step during manufacturing inspection not being performed correctly.
Check the product model number and serial numbers against the specific lists provided in the recall notice.
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-0166-2024 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-0166-2024 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.
