Z-0810-2021Class II

EXOGEN Ultrasound Coupling Gel

Name: Z-0810-2021 EXOGEN Ultrasound Coupling Gel
Creator: Bioventus, LLC
Published: 2020-12-17
License: https://open.fda.gov/license/

Bioventus LLC / initiated 2020-12-17 / Terminated / root cause: manufacturing process

FDA source

Bioventus, LLC began a recall of EXOGEN Ultrasound Coupling Gel on 2020-12-17. FDA classified it as Class II and gives the reason as "Product may contain white particulates that are microbial in nature". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0810-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-17
Posted: 2021-01-09
Terminated: 2024-08-07
Recalling firm: Bioventus LLC
Product: EXOGEN Ultrasound Coupling Gel
Product code: LOF Stimulator, Bone Growth, Non-Invasive
Reason for recall: Product may contain white particulates that are microbial in nature.
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: UDI: M937710344001. Part #71034475, Lot # 190235, 200207; Part # 71034694, Lot # 190235, 190263, 200218, 200228; Part # 71034695, Lot # 190235, 200207; Part # 81079892, Lot # 190204, 190211, 190213, 190226, 190228, 190250, 190251, 190252, 200212, 200215, 200227, 200229, 200240; Part # 81087015, Lot # 190215, 190230, 190235T, 200201, 200203, 200212T, 200215T, 200228T, 200240T

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0810-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0810-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-09

Product code LOF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)