Class 2 Device Recall Neodent

• Date Initiated by Firm: November 30, 2021
• Create Date: January 19, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0512-2022
• Recall Event ID: 89321
• 510(K)Number: K203382
• Product Classification: Implant, endosseous, root-form - Product Code DZE
• Product: Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
• Code Information: Lot GNV17 UDI: 7899878052722
• 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: 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: 7 pieces
• 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