Medtronic Sofamor Danek recalls specific Orthoblend products with packaging defects that may breach sterile barriers. Affected items include DBM S44125, S44135, S44145, S44150, and T44125 series products with listed serial numbers and GTINs.
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 certain Orthoblend products due to potential packaging defects that could breach the sterile barrier. This risk may lead to contamination of the product during use. Affected items include specific DBM product lines with listed serial numbers and GTINs.
The packaging system for these products has defects that could breach the sterile barrier. If the packaging is compromised, the product may become contaminated, potentially leading to infection or other complications during medical procedures.
Patients using these Orthoblend products for bone grafts are most at risk. The recall affects specific product lines with serial numbers and GTINs listed in the notice.
Check if your product has a DBM S44125, S44135, S44145, S44150, or T44125 series with the serial numbers and GTINs listed in the recall notice. The products are used for bone grafts in medical procedures.
Verify if your product matches the specific DBM product lines and serial numbers listed in the recall notice.
The recall affects specific DBM Orthoblend products including DBM S44125, S44135, S44145, S44150, and T44125 series with the serial numbers and GTINs listed in the notice.
Check the product label for the specific DBM product lines and serial numbers listed in the recall notice. The products are used for bone grafts in medical procedures.
Yes, you should check if your product is affected by the recall and contact Medtronic Sofamor Danek if you have any concerns.
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-1326-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1326-2023 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.
