Medtronic Sofamor Danek recalls specific Grafton DBM Matrix Strips (model T42275/T42280) due to potential non-conformances in the outer Tyvek pouch from inspection errors.
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 DBM Matrix Strips (model numbers T42275 and T42280) because a step during Tyvek pouch inspection might have been skipped, potentially allowing non-conforming pouches to be released. This could affect the product's integrity during medical procedures.
The recall stems from a potential failure in the inspection process for the outer Tyvek pouch. If the pouch wasn't properly checked, it might have non-conforming materials that could affect the product's performance during medical procedures.
Patients using these bone graft products for spinal fusion or joint repair. The risk is low as the issue relates to manufacturing inspection, not immediate safety hazards.
Check for model numbers T42275 or T42280 with the specific serial numbers listed in the recall notice. These products are used for bone grafts in spinal fusion or joint repairs.
Verify the model number and serial numbers against the list provided in the recall notice to confirm if your product is affected.
The recall is due to potential non-conformances in the outer Tyvek pouch from a step during inspection that might not have been performed correctly.
Check for model numbers T42275 or T42280 with the specific serial numbers listed in the recall notice.
The recall notice does not specify a remedy, so you should check the product details to confirm if it's affected and contact Medtronic Sofamor Danek for further 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-0164-2024 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-0164-2024 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.
