Device recall
Z-0638-2021: Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone…
FDA device recall · Class II · Biocomposites, Ltd.
Key facts
| Recall number (Z-number) | Z-0638-2021 |
|---|---|
| Recall event | 86755 |
| Product | Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. |
| Product code | MQV |
| Recalling firm | Biocomposites, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2021 |
| 510(k) numbers | K141830 |
| FEI number | 3002806534 |
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