Article No — Class II medical device recall Z-1006-2024
Ongoing recall by Ivoclar Vivadent, Inc., reported 2024-02-14, distributed nationwide. Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical
| Recall number | Z-1006-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ivoclar Vivadent, Inc., Amherst, NY, United States |
| Recall initiated | 2023-12-21 |
| Classified | 2024-02-07 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 2 boxes |
| Reason classes | potency |
| Lot numbers | Z066SD |
Product
Article No. NA6050411, Valiant PhD No. 1 Econo
Reason for recall
Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.
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-1006-2024. 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.