Device recall
Z-0321-2011: Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma…
FDA device recall · Class II · BioHorizons Implant Systems Inc
Key facts
| Recall number (Z-number) | Z-0321-2011 |
|---|---|
| Recall event | 56785 |
| Product | Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244. Endosseous dental implant healing abutment. |
| Product code | DZE |
| Recalling firm | BioHorizons Implant Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 13, 2010 |
| 510(k) numbers | K053152 |
| FEI number | 1000592496 |
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