Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5… recallZ-0512-2022 · Straumann USA LLC · initiated Nov 30, 2021

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Straumann USA LLC or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Packaging change control

What the company is doing

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

Recall details

Recall number: Z-0512-2022
Status: Terminated
Initiated by the company: Nov 30, 2021
Recalling firm: Straumann USA LLC
Quantity: 7 pieces
Product code: DZE
FDA submissions: K203382
Distribution: US Nationwide Distribution in the states of FL, IL, OH

Product description

Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089

Code information (models, lots, serial numbers)

Lot GNV17 UDI: 7899878052722

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Neodent 138.089
JJGC Indústria e Comércio de Materiais Dentários S/A. · IMPLANT, ENDOSSEOUS, ROOT-FORM
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 89321).

Z-0513-2022 · Terminated
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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