Device recall
Z-2155-2008: 3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System…
FDA device recall · Class II · Acumed LLC
Key facts
| Recall number (Z-number) | Z-2155-2008 |
|---|---|
| Recall event | 48468 |
| Product | 3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 ". Polarus Humeral Fixation System, 3.5mm X… |
| Product code | HWC |
| Recalling firm | Acumed LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 3, 2010 |
| 510(k) numbers | K942340 |
| 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