Bioventus recalls 15g sterile bone graft putty due to potential pouch puncture during shipping, which could lead to non-sterile devices and patient infections. Affected items have specific lot numbers and catalog codes.
The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.
Bioventus is recalling 15g sterile bone graft putty products that may have punctured sterile pouches during shipping. This could introduce non-sterile material and cause infections if used in medical procedures.
The sterile pouches for the bone graft putty can get punctured during shipping. If the pouch is punctured, non-sterile material may enter the product, increasing the risk of infection when used in medical procedures.
Medical professionals and patients using the Bioventus Bioactive Bone Graft Putty for bone grafts are affected. Those who have the specific lot numbers listed in the recall are most at risk.
Check the product label for the brand names SIGNAFUSE, OSTEOFUSE, or MEDLINE UNITE. Look for specific lot numbers and catalog codes listed in the recall notice.
Look for the brand names SIGNAFUSE, OSTEOFUSE, or MEDLINE UNITE on the product packaging.
Reach out to Bioventus directly for confirmation of affected items using the lot numbers or catalog codes provided in the recall.
Bioventus became aware that the sterile pouches could be punctured during shipping, which might lead to non-sterile devices and patient infections.
The affected products include 15g sterile bone graft putty with catalog codes SGF-150, OF003, and MSBG150 and specific lot numbers listed in the recall notice.
Check the product label for the brand names SIGNAFUSE, OSTEOFUSE, or MEDLINE UNITE and look for the specific lot numbers or catalog codes provided in the recall.
We’ve drafted a message you can send Bioventus to request your refund or repair — edit it as you like.
Subject: Recall Z-1148-2019 — Bioventus Bioventus Hello, I own a Bioventus that is covered by recall Z-1148-2019 from Bioventus. 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.
