Medtronic recalls Durepair Dura Regeneration Matrix products with potential endotoxin levels that may cause infection-like symptoms. Affected items include specific sizes and expiration dates listed in the recall notice.
Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an acute inflammatory process, comparable to infection.
Medtronic is recalling certain Durepair Dura Regeneration Matrix products due to possible endotoxin levels that could cause infection-like symptoms. These products are used in neurosurgery and were manufactured with specific model numbers and expiration dates.
The Dura regeneration matrix may have endotoxin levels outside the specified range due to testing issues. This can lead to signs and symptoms similar to an infection, such as inflammation, which could be serious in a surgical context.
Patients who have undergone neurosurgery using the recalled Durepair Dura Regeneration Matrix products are most at risk. The products are used in specific surgical procedures and were sold with certain model numbers and expiration dates.
Check for model numbers like DUREPAIR DURA SUBSTITUTE 2 X 2 (61100) or 3 X 3 (61105) with expiration dates listed in the recall notice. The products were sold with specific lot numbers and expiration dates from March 2024 to May 2025.
Identify the model number and expiration date on the product packaging to determine if it is affected.
The Dura regeneration matrix may have endotoxin levels outside the specified range, which can cause signs and symptoms similar to an infection.
Check the model number and expiration date on the product packaging. Affected products include specific sizes like 2 X 2 (61100) or 3 X 3 (61105) with expiration dates from March 2024 to May 2025.
The recall notice does not specify a remedy, so contact Medtronic directly for further instructions.
We’ve drafted a message you can send Medtronic Neurosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-2207-2023 — Medtronic Neurosurgery Medtronic Neurosurgery Hello, I own a Medtronic Neurosurgery that is covered by recall Z-2207-2023 from Medtronic Neurosurgery. 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.
