Device recall
Z-0286-2019: EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone…
FDA device recall · Class I · Zimmer Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-0286-2019 |
|---|---|
| Recall event | 81127 |
| Product | EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions. |
| Product code | LOE |
| Recalling firm | Zimmer Biomet, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 25, 2020 |
| PMA numbers | P790005 |
| FEI number | 1000220733 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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