Device recall
Z-1146-2012: Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The…
FDA device recall · Class III · Sybron Dental Specialties
Key facts
| Recall number (Z-number) | Z-1146-2012 |
|---|---|
| Recall event | 59959 |
| Product | Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material. |
| Product code | ELW |
| Recalling firm | Sybron Dental Specialties |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 14, 2012 |
| 510(k) numbers | K914178 |
| 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