Grandio SO Heavy Flow Caps — Class II medical device recall Z-0028-2020
Terminated recall by Voco GmbH, reported 2019-10-09, distributed in IA, NY. The metal cannula are potentially too loose and may become loose when applying the filing material.
| Recall number | Z-0028-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Voco GmbH, Cuxhaven, N/A, Germany |
| Recall initiated | 2019-07-09 |
| Classified | 2019-10-01 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2023-04-20 |
| Distributed | IA, NY |
| Quantity | 5 units |
| Lot numbers | 1923282 |
| Model numbers | 2706 |
| Expiration dates | 2021-12-28 |
Product
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Reason for recall
The metal cannula are potentially too loose and may become loose when applying the filing material.
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-0028-2020. 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.