Device recall
Z-1233-2014: ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone…
FDA device recall · Class III · Biomet 3i, LLC
Key facts
| Recall number (Z-number) | Z-1233-2014 |
|---|---|
| Recall event | 67194 |
| Product | ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery. |
| Product code | LYC |
| Recalling firm | Biomet 3i, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 11, 2014 |
| 510(k) numbers | K980679 |
| FEI number | 1038806 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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