Device recall
Z-0919-2012: The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient…
FDA device recall · Class II · Novomedicus Llc
Key facts
| Recall number (Z-number) | Z-0919-2012 |
|---|---|
| Recall event | 60844 |
| Product | The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative Pressure Wound Dressing. Contents: Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. Sterile: Contents are sterile for maximum two years unless enclosed package has… |
| Product code | FTL |
| Recalling firm | Novomedicus Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2012 |
| 510(k) numbers | K093166 |
| FEI number | 3008519417 |
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