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U.S. Department of Health and Human Services

Class 2 Device Recall Endosseous dental implant accessory

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  Class 2 Device Recall Endosseous dental implant accessory see related information
Date Initiated by Firm January 24, 2024
Date Posted March 20, 2024
Recall Status1 Open3, Classified
Recall Number Z-1322-2024
Recall Event ID 94040
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product impression coping, repositionable, short, screw-retained, PF 4.0
Code Information Article No. 3.03.079; UDI/DI: 07640156475463; Lot No. 30972.
Recalling Firm/
Manufacturer		 Thommen Medical AG
Eschenweg 3
Bettlach Switzerland
For Additional Information Contact Bibiana Gamper
32644 30 20
Manufacturer Reason
for Recall		 The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
FDA Determined
Cause 2		 Process change control
Action Urgent Field Safety Notice letters dated February 05, 2024 were sent to customers. Customers were instructed to: Ensure that the contents of this Field Safety Notice are read and understood within your organization. Locate and quarantine affected devices immediately. If you have further distributed the product to other organizations, please inform them at once of this FSCA and provide them with a copy of this letter. Return all affected products of the listed lot number to Thommen Medical AG. The products will be replaced by Thommen MedicalAG. Please acknowledge and confirm receipt of this urgent safety information using the enclosed reply form and return it to us together with the retrieved devices. For further questions please contact: Bibiana Gamper Phone: +41 61 965 90 55 E-Mail reoulatory@thommenmedical.com.
Quantity in Commerce 20 units
Distribution US Nationwide distribution in the states of OH and KY.
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.
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