Neodent Easypack Helix GM Acqua 3 — Class II medical device recall Z-0513-2022
Terminated recall by Straumann USA LLC, reported 2022-01-26, distributed nationwide. Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure o
| Recall number | Z-0513-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann USA LLC, Andover, MA, United States |
| Recall initiated | 2021-11-30 |
| Classified | 2022-01-19 |
| Reported by FDA | 2022-01-26 |
| Terminated | 2025-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07899878052906 |
| Lot numbers | GNV20 |
Product
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0513-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.