Device recall
Z-1357-2012: The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an…
FDA device recall · Class II · Acumed LLC
Key facts
| Recall number (Z-number) | Z-1357-2012 |
|---|---|
| Recall event | 61333 |
| Product | The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is labeled in part: "Polarus Humeral Fixation System Size: 8mm X 240mm Polarus Plus Humeral… |
| Product code | HSB |
| Recalling firm | Acumed LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2012 |
| 510(k) numbers | K951740 |
| FEI number | 1000125930 |
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