Device recall
Z-1658-2013: ***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN…
FDA device recall · Class II · The Anspach Effort, Inc.
Key facts
| Recall number (Z-number) | Z-1658-2013 |
|---|---|
| Recall event | 64973 |
| Product | ***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be… |
| Product code | NAV |
| Recalling firm | The Anspach Effort, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 24, 2013 |
| FEI number | 1045834 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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