Device recall
Z-0186-2012: Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The…
FDA device recall · Class II · Kerr/pentron Dba Kerr Corporation And Pentron Clinical
Key facts
| Recall number (Z-number) | Z-0186-2012 |
|---|---|
| Recall event | 60242 |
| Product | Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations. |
| Product code | EMA |
| Recalling firm | Kerr/pentron Dba Kerr Corporation And Pentron Clinical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 2013 |
| 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