Straumann USA LLC Recall 89321
Description: Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Straumann USA LLC Recall 89321 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0512-2022 |
| Event ID | 89321 |
| Event Description | Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution in the states of FL, IL, OH |
| Quantity | 7 pieces |
| Recall 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 |
| Device Classification | 20220126 |
| Device Code Info | Lot GNV17 UDI: 7899878052722 |
| Center Classification Date | 20220119 |
| Recall Initiation Date | 20211130 |
| Recalling Firm | Straumann USA LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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