Lower risk Medical device recall · FDA · Published February 13, 2019

Bioventus Bioactive Bone Graft Putty 15g: Risk of infection from punctured sterile pouch

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1148-2019Medical device Bioventus ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmBioventus, LLC1900 Charles Bryan Rd Ste 275 · Cordova, TN 38016-5285

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/69007-bioventus-bioactive-bone-graft-putty-15g-risk-of-infection-from.

Source Summary by GovInfoNow · govinfonow.com/recall/69007-bioventus-bioactive-bone-graft-putty-15g-risk-of-infection-from · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1148-2019

Cite this page

“Bioventus Bioactive Bone Graft Putty 15g: Risk of infection from punctured sterile pouch.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69007-bioventus-bioactive-bone-graft-putty-15g-risk-of-infection-from. Based on FDA recall #Z-1148-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1148-2019%22&limit=1).

The FDA announced on Feb. 13, 2019, that Bioventus, LLC voluntarily recalled BIOVENTUS Bioactive Bone Graft Putty 15g due to potential sterile pouch punctures during transit. The packaging failure may introduce a non-sterile device that could lead to patient infection.

How to tell if you have it

Brand: BIOVENTUS
Product names: SIGNAFUSE, OSTEOFUSE, MEDLINE UNITE
Catalog #: SGF-150, OF003, MSBG150
Lot numbers: N737 00104 through Z737 00110 (SGF-150); N837 00144, Q737 00121, Q837 00156, S837 00165, T437 00017, Y637 00100, Z737 00107 (OF003); R837 00160 (MSBG1500)

The hazard

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.

Context

GovInfoNow's records show Bioventus, LLC has one other recall on record since Dec. 17, 2020: the EXOGEN Ultrasound Gel Recall for microbial particulates hazard. Other recent recalls of similar products include Boston Scientific Radial Jaw 4 Biopsy Forceps (June 30, 2026), Boston Scientific Radial Jaw 4 Jumbo Biopsy Forceps (June 30, 2026), and Medical Action Industries Blood Culture Kits (July 23, 2026).

How to tell if you have this one

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.

Brand
Bioventus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the brand names SIGNAFUSE, OSTEOFUSE, or MEDLINE UNITE on the product packaging.
Contact Manufacturer
Reach out to Bioventus directly for confirmation of affected items using the lot numbers or catalog codes provided in the recall.

Where it went and when

Where it was distributed

Distributed in 28 states and D.C..

FDA distribution: “AK, AZ, CA, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NV, OH, OR, TN, TX, UT, WA, and WY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, North Carolina, Ohio, Oregon, Tennessee, Texas, Utah, Washington, Wyoming.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Feb 13, 2019Firm started the recall
Apr 15, 2019FDA classified it Class II
Apr 24, 2019Published in FDA’s Enforcement Report
Nov 2, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/69007-bioventus-bioactive-bone-graft-putty-15g-risk-of-infection-from">Bioventus Bioactive Bone Graft Putty 15g: Risk of infection from punctured sterile pouch (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1148-2019 (February 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1148-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.