Recall of specific Grafton DBM Orthoblend models due to potential non-conformances in the outer Tyvek pouch from inspection steps. Affected units include model numbers T44125INT, T44135, T44145, T44150 with listed serial numbers.
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 Orthoblend products with model numbers T44125INT, T44135, T44145, and T44150. The recall is due to a potential issue where the outer Tyvek pouch may not have been inspected properly during manufacturing, which could lead to non-conformances in the pouch. This affects patients using these products for bone grafts.
The hazard involves a potential failure in the inspection process of the outer Tyvek pouch during manufacturing. If the inspection steps were not followed correctly, the pouch may have non-conformances that could affect the product's integrity and safety.
Patients using Grafton DBM Orthoblend for bone grafts are most at risk. The recall applies to specific model numbers and serial numbers listed in the record.
Check the product model number (T44125INT, T44135, T44145, or T44150) and the serial numbers listed in the recall notice. The product is a demineralized bone matrix used for bone grafts.
Identify the model number and serial numbers from the list provided in the recall notice to confirm if your product is affected.
The recall is due to a potential issue where the outer Tyvek pouch may not have been inspected properly during manufacturing, which could lead to non-conformances in the pouch.
Check the model number and serial numbers against the list provided in the recall notice to see if your product is affected. If it is, you should contact Medtronic Sofamor Danek for further instructions.
The recall indicates a potential issue with the outer Tyvek pouch, but the hazard is described as a possible non-conformance that does not necessarily pose an immediate safety risk.
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-0165-2024 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-0165-2024 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.
