# FDA recall Z-1148-2019

> **Bioventus, LLC** · Class II · device recall initiated 2019-02-13.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1148-2019
- **Recalling firm:** Bioventus, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-13
- **Report date:** 2019-04-24
- **Termination date:** 2020-11-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cordova, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1148-2019

## Citation

> AI Analytics. FDA recall Z-1148-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1148-2019. Source: US FDA. Licensed CC0.

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