Device recall
Z-0390-2012: Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g…
FDA device recall · Class II · Henry Schein, Inc.
Key facts
| Recall number (Z-number) | Z-0390-2012 |
|---|---|
| Recall event | 60407 |
| Product | Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips (wide) 4:1, 10 Intra-oral tips Dental resin cement. Self-etch, self-adhesive resin cement. High bond… |
| Product code | EMA |
| Recalling firm | Henry Schein, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 3, 2018 |
| 510(k) numbers | K073209 |
| FEI number | 1000522050 |
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