Z-0513-2022Class II

Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107

Name: Z-0513-2022 Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Creator: Straumann USA LLC
Published: 2021-11-30
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2021-11-30 / Terminated / root cause: packaging

FDA source

Straumann USA LLC began a recall of Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 on 2021-11-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0513-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-30
Posted: 2022-01-19
Terminated: 2025-02-05
Recalling firm: Straumann USA, LLC
Product: Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Product code: DZE Implant, Endosseous, Root-Form
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
Root cause tag: packaging
FDA root 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: 1 unit
Distribution: US Nationwide Distribution in the states of FL, IL, OH
Product codes and lots: Lot GNV20: UDI:7899878052906

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0513-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0512-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-26	2022-01-19
Z-0513-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-26	2022-01-19

Product code DZE

K203382Class IINeodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A. / cleared 2021-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)