Device recall
Z-0401-2021: COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed…
FDA device recall · Class II · Merz North America, Inc.
Key facts
| Recall number (Z-number) | Z-0401-2021 |
|---|---|
| Recall event | 86572 |
| Product | COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and… |
| Product code | LNM |
| Recalling firm | Merz North America, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P040047 |
| 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