Device recall
Z-1917-2018: ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform…
FDA device recall · Class II · Implant Direct Sybron Manufacturing, LLC
Key facts
| Recall number (Z-number) | Z-1917-2018 |
|---|---|
| Recall event | 79793 |
| Product | ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of… |
| Product code | DZE |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 4, 2018 |
| 510(k) numbers | K130572 |
| 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