Device recall
Z-0923-03: Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill…
FDA device recall · Class II · Implant Innovations, Inc.
Key facts
| Recall number (Z-number) | Z-0923-03 |
|---|---|
| Recall event | 26370 |
| Product | Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only. |
| Product code | DZE |
| Recalling firm | Implant Innovations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 3, 2012 |
| 510(k) numbers | K736396 |
| 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