—#191259

Product

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

FDA product code: DZE — Implant, Endosseous, Root-Form
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K203382
Affected lot / code info: Lot GNV17 UDI: 7899878052722

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

Root cause (FDA determination)

Packaging change control

Action the firm took

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

Recalling firm

Firm: Straumann USA LLC
Address: 60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

Distribution pattern: US Nationwide Distribution in the states of FL, IL, OH

Timeline

Recall initiated: 2021-11-30
Terminated: 2025-02-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191259. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.