Device recall
Z-0924-03: Products are surgical drills packaged separately or included in a surgical kit…
FDA device recall · Class II · Implant Innovations, Inc.
Key facts
| Recall number (Z-number) | Z-0924-03 |
|---|---|
| Recall event | 26370 |
| Product | Products are surgical drills packaged separately or included in a surgical kit so two products will be listed. The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 OsseoFix System Complete (Kit)3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL… |
| 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