Device recall
Z-0692-2007: BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc…
FDA device recall · Class III · BioHorizons Implant Systems Inc
Key facts
| Recall number (Z-number) | Z-0692-2007 |
|---|---|
| Recall event | 37687 |
| Product | BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377. |
| Product code | DZE |
| Recalling firm | BioHorizons Implant Systems Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 4, 2007 |
| 510(k) numbers | K963951 |
| 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