Device recall
Z-1000-2019: Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT…
FDA device recall · Class II · Ossur Americas
Key facts
| Recall number (Z-number) | Z-1000-2019 |
|---|---|
| Recall event | 80520 |
| Product | Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/ CB Resolve Sterile Unit LRG; 515300C/ CB RESOLVE RING KIT SM-No App; 515400C/ CB RESOLVE RING KIT STD-No App; 515500C/ CB RESOLVE RING KIT LG-No App; 540C/ CB RESOLVE… |
| 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