Device recall
Z-0797-2019: Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage…
FDA device recall · Class II · Handpiece Headquarters
Key facts
| Recall number (Z-number) | Z-0797-2019 |
|---|---|
| Recall event | 81459 |
| Product | Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY. |
| Product code | EBZ |
| Recalling firm | Handpiece Headquarters |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K060646 |
| FEI number | 3007007357 |
At a glance
- 1–9 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