Device recall
Z-0607-2018: Synvisc-One (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A…
FDA device recall · Class II · Sanofi Genzyme
Key facts
| Recall number (Z-number) | Z-0607-2018 |
|---|---|
| Recall event | 78792 |
| Product | Synvisc-One (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-One is administered as a single intra-articular injection. Synvisc-One is indicated for the treatment… |
| Product code | MOZ |
| Recalling firm | Sanofi Genzyme |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2023 |
| PMA numbers | P940015 |
| FEI number | 1000305672 |
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