Device recall
Z-1076-2013: Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No…
FDA device recall · Class II · Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Key facts
| Recall number (Z-number) | Z-1076-2013 |
|---|---|
| Recall event | 64559 |
| Product | Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations. |
| Product code | MZW |
| Recalling firm | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 22, 2014 |
| 510(k) numbers | K073209 |
| FEI number | 2024312 |
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