Medtronic Sofamor Danek recalls Medtronic Accelerate Grafton DBF products with specific serial numbers due to potential packaging non-conformances that could breach the sterile barrier.
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Medtronic Sofamor Danek is recalling specific models of Medtronic Accelerate Grafton DBF products because their packaging might not be sterile, which could lead to contamination. This recall affects certain products with listed serial numbers.
The packaging for these products may not meet sterile standards, which could lead to a breach in the sterile barrier. This might result in contamination of the product, but the recall indicates this is a low-risk issue.
Patients using the Medtronic Accelerate Grafton DBF products with the specific serial numbers listed in the recall are affected. The risk is low as the packaging issue is not expected to cause serious injury.
Check if your Medtronic Accelerate Grafton DBF product has the serial numbers listed in the recall notice. The products include specific models with GTIN numbers and serial numbers provided in the recall.
Compare your product's serial numbers with the list provided in the recall notice to determine if it is affected.
The recall affects Medtronic Accelerate Grafton DBF products with specific serial numbers listed in the recall notice, including models T50203, T50206, T50209, and T50212.
Check your product's serial numbers against the list of affected serial numbers provided in the recall notice.
The recall does not specify a remedy, so you should check with Medtronic Sofamor Danek for further instructions.
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-1332-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1332-2023 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.
