Device recall
Z-0842-2017: BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous…
FDA device recall · Class II · Biomet 3i, LLC
Key facts
| Recall number (Z-number) | Z-0842-2017 |
|---|---|
| Recall event | 75761 |
| Product | BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation |
| Product code | NHA |
| Recalling firm | Biomet 3i, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 26, 2019 |
| 510(k) numbers | K092341 |
| FEI number | 1038806 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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