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U.S. Department of Health and Human Services

Class 2 Device Recall EXOGEN Ultrasound Coupling Gel

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 Class 2 Device Recall EXOGEN Ultrasound Coupling Gelsee related information
Date Initiated by FirmDecember 17, 2020
Create DateJanuary 09, 2021
Recall Status1 Terminated 3 on August 07, 2024
Recall NumberZ-0810-2021
Recall Event ID 87002
PMA NumberP900009 
Product Classification Stimulator, bone growth, non-invasive - Product Code LOF
ProductEXOGEN Ultrasound Coupling Gel
Code Information 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
FEI Number 3027669735
Recalling Firm/
Manufacturer		 Bioventus, LLC
1900 Charles Bryan Rd Ste 275
Cordova TN 38016-5285
For Additional Information ContactThomas Hill
919-474-6715
Manufacturer Reason
for Recall		Product may contain white particulates that are microbial in nature.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionDevice 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 Commerce115,584 units
DistributionUnited 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
PMA DatabasePMAs with Product Code = LOF
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