Device recall
Z-0396-2016: DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A…
FDA device recall · Class II · Implant Direct Sybron Manufacturing, LLC
Key facts
| Recall number (Z-number) | Z-0396-2016 |
|---|---|
| Recall event | 72549 |
| Product | DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place. |
| Product code | NHA |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 8, 2016 |
| 510(k) numbers | K081396 |
| FEI number | 3001617766 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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