Device recall
Z-1001-2019: Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2…
FDA device recall · Class II · Ossur Americas
Key facts
| Recall number (Z-number) | Z-1001-2019 |
|---|---|
| Recall event | 80520 |
| Product | Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; 505400T/ CB RING KIT TI STD; 505400V2/ OB V2 RING KIT TI STD; 505500T/ CB RING KIT TI LG; 505500V2/ OB V2 RING KIT TI LG; 515300V2/ OB V2 RING KIT TI SM-No App; 515400V2/ OB V2 RING KIT TI STD-No App… |
| Product code | HAX |
| Recalling firm | Ossur Americas |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2020 |
| 510(k) numbers | K051918 |
| FEI number | 1000519909 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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