Recall Z-0512-2022 ยท DZE Implant, Endosseous, Root-Form
Straumann USA LLC
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
| Date | Nov 30, 2021 |
| Status | Terminated |
| Reason | 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 | 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 p |
| Quantity | 7 pieces |
| Distribution | US Nationwide Distribution in the states of FL, IL, OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203382 | Neodent Implant System-Easy Pack Jjgc Industria E Comercio DE Materiais Dentarios S.A., Mar 15, 2021 |