Cordova, TN, United States
Bioventus, LLC recalls
2 recalls recorded since 2018, most recently on 17 December 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 17 December 2020
- Terminated
- 7 August 2024
- Reason
- Product may contain white particulates that are microbial in nature.
- Distribution
- United States (Nationwide), Australia, Austria, Belgium, Canada, Cyprus, Denmark, France, Germany, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0810-2021
- EXOGEN Ultrasound Coupling Gel
Terminated Class II Medical devices
- Recall started
- 13 February 2019
- Terminated
- 2 November 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1148-2019
- 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, OST
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.