Device recall
Z-2963-2018: Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm…
FDA device recall · Class II · Zimmer Dental Inc
Key facts
| Recall number (Z-number) | Z-2963-2018 |
|---|---|
| Recall event | 80609 |
| Product | Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a… |
| Product code | DZE |
| Recalling firm | Zimmer Dental Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2020 |
| 510(k) numbers | K111889 |
| FEI number | 1038806 |
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