Device recall
Z-0653-2013: UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description…
FDA device recall · Class II · Surgical Tissue Network, Inc.
Key facts
| Recall number (Z-number) | Z-0653-2013 |
|---|---|
| Recall event | 63226 |
| Product | UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a… |
| Product code | MQV |
| Recalling firm | Surgical Tissue Network, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 2, 2014 |
| FEI number | 3003564213 |
At a glance
- None 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