Device recall
Z-2097-2016: IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC…
FDA device recall · Class II · CMP Industries, Llc
Key facts
| Recall number (Z-number) | Z-2097-2016 |
|---|---|
| Recall event | 74061 |
| Product | IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3)… |
| Product code | EBI |
| Recalling firm | CMP Industries, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 25, 2018 |
| 510(k) numbers | K033020 |
| FEI number | 1315551 |
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