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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 Gel see related information
Date Initiated by Firm December 17, 2020
Create Date January 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-0810-2021
Recall Event ID 87002
PMA Number P900009 
Product Classification Stimulator, bone growth, non-invasive - Product Code LOF
Product EXOGEN 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
Recalling Firm/
Manufacturer		 Bioventus, LLC
1900 Charles Bryan Rd Ste 275
Cordova TN 38016-5285
For Additional Information Contact Thomas 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
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
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LOF and Original Applicant = BIOVENTUS LLC
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