Device recall
Z-0145-2012: MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part…
FDA device recall · Class II · Merz Aesthetics, Inc.
Key facts
| Recall number (Z-number) | Z-0145-2012 |
|---|---|
| Recall event | 60046 |
| Product | MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number 8071M5 distributed in Europe/Middle East/Africa Part Number 8071M9 distributed in Hong Kong, Korea, Malaysia. |
| Product code | LMH |
| Recalling firm | Merz Aesthetics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 1, 2012 |
| PMA numbers | P050037, P050052 |
| FEI number | 3003407669 |
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