Device recall
Z-1965-2009: iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box…
FDA device recall · Class II · Theken Spine LLC
Key facts
| Recall number (Z-number) | Z-1965-2009 |
|---|---|
| Recall event | 52798 |
| Product | iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04. |
| Product code | MQV |
| Recalling firm | Theken Spine LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 9, 2012 |
| 510(k) numbers | K040134 |
| FEI number | 3002498892 |
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