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Class 2 Device Recall EXOGEN Ultrasound Coupling Gel |
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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
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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
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For Additional Information Contact |
Thomas Hill 919-474-6715
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Manufacturer Reason for Recall |
Product may contain white particulates that are microbial in nature.
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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
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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.
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PMA Database |
PMAs with Product Code = LOF and Original Applicant = BIOVENTUS LLC
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