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U.S. Department of Health and Human Services

Class 2 Device Recall Neodent Implant Systems GM Helix Acqua Implant

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  Class 2 Device Recall Neodent Implant Systems GM Helix Acqua Implant see related information
Date Initiated by Firm October 11, 2021
Create Date November 04, 2021
Recall Status1 Open3, Classified
Recall Number Z-0203-2022
Recall Event ID 88917
510(K)Number K163194  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product GM Helix Acqua Implant 3.5x10, Article No. 140.944
Code Information UDI 7899878024897 Lots GNW15 and GRE82
Recalling Firm/
Manufacturer
Jjgc Industria E Comercio De Materials Dentarios Sa
Av Juscelino Kubitschek De Oliveira
Curitiba Brazil
Manufacturer Reason
for Recall
3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm initially contacted affected customers by phone on October 11, 2021. Customers were instructed to immediately stop using the product and to place all impacted product in quarantine. The firm then followed up with a confirmation letter sent by UPS on October 22, 2021. Customers were instructed to identify and segregate the affected units, open or closed, in their stock. Product is to be returned to the manufacturer.' If product has been installed and the patient reports an issue (such as numbness, pain, or other symptoms), please notify the distributor immediately to receive instructions on how to proceed.
Quantity in Commerce 567 (US)
Distribution US Nationwide distribution.
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 SA
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