Device recall
Z-0169-2011: Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is…
FDA device recall · Class II · Theken Spine Llc
Key facts
| Recall number (Z-number) | Z-0169-2011 |
|---|---|
| Recall event | 56858 |
| Product | Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different… |
| Product code | NOX |
| Recalling firm | Theken Spine Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2011 |
| 510(k) numbers | K053228 |
| FEI number | 3002498892 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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