Device recall
Z-2221-2011: Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam…
FDA device recall · Class III · Merz Aesthetics, Inc.
Key facts
| Recall number (Z-number) | Z-2221-2011 |
|---|---|
| Recall event | 58614 |
| Product | Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #10 Franksville, WI 53126. Subdermal implantation for the correction of moderate to severe facial wrinkles and folds… |
| Product code | LMH |
| Recalling firm | Merz Aesthetics, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 17, 2011 |
| 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