Device recall
Z-2375-2008: FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then…
FDA device recall · Class III · Theken Spine LLC
Key facts
| Recall number (Z-number) | Z-2375-2008 |
|---|---|
| Recall event | 49018 |
| Product | FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates. |
| Product code | MQV |
| Recalling firm | Theken Spine LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 20, 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
- 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