Device recall
Z-1651-2014: Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical…
FDA device recall · Class II · Heraeus Kulzer, LLC.
Key facts
| Recall number (Z-number) | Z-1651-2014 |
|---|---|
| Recall event | 68223 |
| Product | Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed… |
| Product code | LBH |
| Recalling firm | Heraeus Kulzer, LLC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 5, 2014 |
| FEI number | 1821514 |
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