Device recall
Z-1100-2012: Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for…
FDA device recall · Class II · Kerr Corporation
Key facts
| Recall number (Z-number) | Z-1100-2012 |
|---|---|
| Recall event | 61235 |
| Product | Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts. |
| Product code | EMA |
| Recalling firm | Kerr Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2012 |
| 510(k) numbers | K060698 |
| FEI number | 2024312 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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