Device recall
Z-2373-2016: OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID…
FDA device recall · Class II · Ivoclar Vivadent, Inc.
Key facts
| Recall number (Z-number) | Z-2373-2016 |
|---|---|
| Recall event | 74622 |
| Product | OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam. |
| Product code | EHJ |
| Recalling firm | Ivoclar Vivadent, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 22, 2017 |
| FEI number | 1316092 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database