BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile — Class II medical device recall Z-1148-2019
Terminated recall by Bioventus, LLC, reported 2019-04-24, distributed in AK, AZ, CA, CO, DC, FL, GA, IA…. The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The pac
| Recall number | Z-1148-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bioventus, LLC, Cordova, TN, United States |
| Recall initiated | 2019-02-13 |
| Classified | 2019-04-15 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-11-02 |
| Distributed | 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, WY |
| Quantity | 10,793 |
| Reason classes | sterility, packaging |
| Lot numbers | 00016, 00017, 00063, 00065, 00067, 00068, 00071, 00072, 00075, 00077, 00079, 00080, 00084, 00088, 00089, 00090, 00093, 00094, 00095, 00098, 00100, 00104, 00105, 00107, 00109, 00110, 00113, 00114, 00115, 00119, 00120, 00121, 00122, 00123, 00124, 00127, 00128, 00129, 00130, 00134 and 73 more |
| Model numbers | 150, MSBG150SGF, OF003, SGF-150 |
Product
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.
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1148-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.