Medtronic Sofamor Danek recalls XPANSE Bone Insert products with specific model numbers and serial ranges 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 several models of XPANSE Bone Insert products because their packaging might not be sterile, which could lead to contamination. This recall affects specific model numbers and serial ranges listed in the notice.
The packaging for these products uses a dual-barrier sterile pouch system that may have non-conformances. If the packaging is compromised, it could breach the sterile barrier, potentially leading to contamination of the product.
Patients who have received the recalled XPANSE Bone Insert products for spinal fusion surgery are most at risk. The recall applies to specific model numbers and serial ranges listed in the official notice.
Check the product model number and serial numbers listed in the recall notice. The affected products include specific model numbers like DBM T600106 XPANSE SMALL-C 6 and DBM T600206 XPANSE MEDIUM-C 6, along with their associated serial ranges.
Identify the model number and serial numbers on your XPANSE Bone Insert product to see if it matches the recalled items listed in the notice.
The recall affects specific model numbers and serial ranges of Medtronic XPANSE Bone Insert products, including DBM T600106 XPANSE SMALL-C 6, DBM T600206 XPANSE MEDIUM-C 6, and others with the serial numbers listed in the notice.
If your product is not listed in the recall notice, it is not affected by this recall. Check the model number and serial numbers against the provided list to confirm.
The recall is due to potential packaging non-conformances that could breach the sterile barrier. However, the hazard level is low risk as the products are not expected to cause serious injury under normal use.
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-1334-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1334-2023 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.
