Device recall
Z-1744-2015: The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun…
FDA device recall · Class II · BIOMET FRANCE S.A.R.L.
Key facts
| Recall number (Z-number) | Z-1744-2015 |
|---|---|
| Recall event | 71365 |
| Product | The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac. |
| Product code | KIH |
| Recalling firm | BIOMET FRANCE S.A.R.L. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2015 |
| FEI number | 3006946279 |
At a glance
- None 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