Device recall
Z-0915-2012: Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The…
FDA device recall · Class II · Kerr Corporation
Key facts
| Recall number (Z-number) | Z-0915-2012 |
|---|---|
| Recall event | 60685 |
| Product | Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material… |
| Product code | MZW |
| Recalling firm | Kerr Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 31, 2012 |
| 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