Device recall
Z-0360-2017: SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm…
FDA device recall · Class II · Unomedical As
Key facts
| Recall number (Z-number) | Z-0360-2017 |
|---|---|
| Recall event | 74242 |
| Product | SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with… |
| Product code | FPA |
| Recalling firm | Unomedical As |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 16, 2016 |
| 510(k) numbers | K041545 |
| FEI number | 1000477110 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 1,000+ 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