Recall Z-0810-2021 ยท LOF Stimulator, Bone Growth, Non-Invasive
Bioventus, LLC
EXOGEN Ultrasound Coupling Gel
| Date | Dec 17, 2020 |
| Status | Terminated |
| Reason | Product may contain white particulates that are microbial in nature. |
| Root cause | Nonconforming Material/Component |
| Action | Device Recall Notice 3010203571-12/14/20-001-R was sent to customers beginning 12/17/2020. Customers were instructed to dispose of the product and verify disposal lot and quantity. |
| Quantity | 115,584 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.