Device recall
Z-2046-2016: 6534-08N InterActive Implant Open-Tray Transfer Narrow Part Number: 6534-08N…
FDA device recall · Class II · Implant Direct Sybron Manufacturing, LLC
Key facts
| Recall number (Z-number) | Z-2046-2016 |
|---|---|
| Recall event | 74208 |
| Product | 6534-08N InterActive Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible or maxilla. Open Tray transfers stay within the Impression material prior to… |
| Product code | EHY |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2016 |
| FEI number | 3001617766 |
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