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U.S. Department of Health and Human Services

Class 2 Device Recall Straumann Emdogain

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 Class 2 Device Recall Straumann Emdogainsee related information
Date Initiated by FirmOctober 17, 2025
Date PostedNovember 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0582-2026
Recall Event ID 97753
PMA NumberP930021 
Product Classification Biologic material, dental - Product Code NQA
ProductEmdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Code Information 1. Article Number: 440.230V10; UDI-DI: N/A; Lot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80; 2. Article Number: 475.132V10; UDI-DI: N/A; Lot Numbers: CRL56, HPHJ1;
FEI Number 1000121052
Recalling Firm/
Manufacturer		 Straumann USA LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information ContactJennifer M. Jackson, MS, RAC
978-747-2560
Manufacturer Reason
for Recall		The possibility for this product that is intended for demonstration purposes only to be placed in patients.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn October 17, 2025 Urgent Field Safety Action letters were sent to customers. Action to be taken: 1. 1. Check your inventory for the affected article/lot numbers. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. Please return the affected items to the attention of Jennifer Jackson at Straumann USA, LLC for credit as indicated on the Customer Confirmation Form. 2. 2. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided. Transmission of the Field Safety Notice This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. The Food and Drug Administration (FDA) has been informed about this Field Safety Corrective Action. We apologize for any inconvenience that this may cause.
Quantity in Commerce61 units
DistributionUS Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
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 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 DatabasePMAs with Product Code = NQA
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