Medtronic Sofamor Danek USA Inc recalls specific Grafton Putty products (0.5cc, 1cc, 2.5cc, 5cc, 10cc) due to potential packaging non-conformances that could breach the sterile barrier. Affected units have serial numbers listed in the recall notice.
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 Grafton Putty products (0.5cc, 1cc, 2.5cc, 5cc, and 10cc) because their packaging may not meet sterile requirements. This could lead to a breach in the sterile barrier, potentially exposing the product to contamination.
The packaging system for these products uses a dual-barrier sterile pouch. If the packaging is non-conforming, it could breach the sterile barrier, potentially exposing the product to contamination during use.
Patients using these Grafton Putty products for medical procedures are most at risk. The recall affects specific product sizes with serial numbers listed in the notice.
Check your Grafton Putty product for the following sizes: 0.5cc, 1cc, 2.5cc, 5cc, or 10cc. Affected units have specific serial numbers listed in the recall notice.
Look for serial numbers on the product packaging to determine if it's affected. Affected units have specific serial numbers listed in the recall notice.
Medtronic Sofamor Danek is recalling specific Grafton Putty products (0.5cc, 1cc, 2.5cc, 5cc, and 10cc) due to potential packaging non-conformances that could breach the sterile barrier.
Check your product's serial numbers against the list provided in the recall notice. Affected units have specific serial numbers listed in the notice.
The recall does not specify a remedy, so no action is required beyond checking if your product is affected.
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-1323-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1323-2023 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.
