Device recall
Z-1621-2012: a translucent, rectangular, resorbable, collagen membrane sheet derived from…
FDA device recall · Class II · Kensey Nash Corp
Key facts
| Recall number (Z-number) | Z-1621-2012 |
|---|---|
| Recall event | 61819 |
| Product | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only… |
| Product code | NPL |
| Recalling firm | Kensey Nash Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2013 |
| 510(k) numbers | K090919 |
| FEI number | 1000307073 |
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