Device recall
Z-1003-2019: Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt…
FDA device recall · Class II · Ossur Americas
Key facts
| Recall number (Z-number) | Z-1003-2019 |
|---|---|
| Recall event | 80520 |
| Product | Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt lmbwool; 545800K/ ReSolve Halo Vest-tall kodel; 545800L/ ReSolve Halo Vest-tall lmbwool |
| Product code | KQZ |
| Recalling firm | Ossur Americas |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2020 |
| FEI number | 1000519909 |
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