Device recall
Z-0335-2022: OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF…
FDA device recall · Class II · Osteomed, LLC
Key facts
| Recall number (Z-number) | Z-0335-2022 |
|---|---|
| Recall event | 88990 |
| Product | OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power… |
| Product code | KMW |
| Recalling firm | Osteomed, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K971692 |
| FEI number | 2027754 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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