Device recall
Z-0010-2020: ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF…
FDA device recall · Class II · Implant Direct Sybron Manufacturing, LLC
Key facts
| Recall number (Z-number) | Z-0010-2020 |
|---|---|
| Recall event | 83086 |
| Product | ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. |
| Product code | DZE |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC |
| Recall class | Class II |
| Status | Terminated |
| 510(k) numbers | K061319 |
| 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