BIOVENTUS Bioactive Bone Graft Putty 15g
Medical device recall Z-1148-2019. Published in FDA’s Enforcement Report on Apr 24, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 24, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 29 states named in where it went
- 10,793 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE.
10,793, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog #s SGF-150, OF003, and MSBG150 SGF 150 LOT NUMBERS N737 00104, N737 00105, N837 00146, N837 00147, N837 00148, N937 00196, N937 00197, N937 00198, N937 00199, P637 00065, P637 00067, P637 00068, P737 00113, P737 00114, P737 00115,…
Every code shown here, 1,039 characters
Catalog #s SGF-150, OF003, and MSBG150 SGF 150 LOT NUMBERS N737 00104, N737 00105, N837 00146, N837 00147, N837 00148, N937 00196, N937 00197, N937 00198, N937 00199, P637 00065, P637 00067, P637 00068, P737 00113, P737 00114, P737 00115, P837 00149, P837 00152, P837 00153, Q737 00119, Q737 00120, Q837 00157, R637 00071, R637 00072, R637 00075, R737 00122, R837 00163, R837 00164, S437 00016, S737 00123, S837 00169, T637 00077, T637 00079, T737 00124, T737 00127, T837 00170, T837 00171, T837 00172, T837 00173, T837 00176, U637 00080, U637 00084, U737 00128, U737 00129, U837 00180, U837 00181, U837 00182, V637 00088, V637 00089, V737 00130, V737 00134, V837 00183, V837 00184, V837 00185, V837 00186, W637 00090, W737 00135, W737 00136, W737 00137, X637 00093, X637 00094, X637 00095, X737 00139, X837 00189, X837 00190, X837 00191, Y637 00098, Y737 00141, Z637 00063, Z737 00109, and Z737 00110. OF003 LOT NUMBERS N837 00144, Q737 00121, Q837 00156, S837 00165, T437 00017, Y637 00100, and Z737 00107. MSBG1500 LOT NUMBER R837 00160
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
29 states and territories.
Every one of them
- Alaska
- Arizona
- California
- Colorado
- District of Columbia
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Missouri
- North Carolina
- Nebraska
- New Jersey
- Nevada
- Ohio
- Oregon
- Tennessee
- Texas
- Utah
- Washington
- Wyoming
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 13, 2019.
- FDA classified it on Apr 15, 2019.
- FDA’s Enforcement Report published it on Apr 24, 2019.
- FDA terminated it on Nov 2, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Bioventus, LLC, of Cordova, TN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.