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U.S. Department of Health and Human Services

Class 2 Device Recall Neodent

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  Class 2 Device Recall Neodent see related information
Date Initiated by Firm November 30, 2021
Create Date January 19, 2022
Recall Status1 Open3, Classified
Recall Number Z-0513-2022
Recall Event ID 89321
510(K)Number K203382  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5
Article Number: 138.107
Code Information Lot GNV20:  UDI:7899878052906
Recalling Firm/
Manufacturer		 Straumann USA LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information Contact Loretta Mooney
978-747-2560
Manufacturer Reason
for Recall		 Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
FDA Determined
Cause 2		 Packaging change control
Action Neodent issued Medical Device Recall letter initial contact by phone initiated on November 30th, 2021; followed by Confirmation written letter via UPS December 3rd 2021. Letter states reason for recall, health risk and action to take: Search in your stock for units according to the description on the table above. " If the implant has not yet been used, identify and segregate the affected units, open or closed, in your stock. Return the product using the label included in this mailing, refer to Field Action . Upon receipt of the product by Straumann, replacement product will be sent. If the product is not found in your inventory, indicate on the Form below. " If the product has been implanted and no issue was identified, it is not necessary to remove, additional patient follow-up is not required. Indicate this on the Customer Confirmation Form (included) " If the product has been installed and an issue has been reported by the patient, for example: numbness, pain or any other symptom, please communicate immediately to Straumann. " For either cases, complete and return the enclosed Customer Confirmation Form to Action 003/2021. 3.1. DATA FOR PRODUCT RETURN: Straumann USA Regulatory Affairs Action 003/2021 Product Return 60 Minuteman Road, Andover, MA 01810
Quantity in Commerce 1 unit
Distribution US Nationwide Distribution in the states of FL, IL, OH
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.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = JJGC Industria e Comercio de Materiais Dentarios S.A.
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