FDA Device recall Z-0513-2022
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
- FDA Device
- Class II
- terminated
- Published 2022-01-26
On 2022-01-26 the FDA classified a Class II recall of Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 by Straumann Usa, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0513-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-30 |
| Published | 2022-01-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Straumann Usa |
| Distribution | US |
Product
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
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
Identifiers
| code_info | Lot GNV20: UDI:7899878052906 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0513-2022%22
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