Device recall
Z-0405-2020: Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B…
FDA device recall · Class II · Tornier, Inc
Key facts
| Recall number (Z-number) | Z-0405-2020 |
|---|---|
| Recall event | 84033 |
| Product | Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603B 3700386944543 DWF603C 3700386944550 DWF604A 3700386944567 DWF604B 3700386944574 DWF605A… |
| Product code | PHX |
| Recalling firm | Tornier, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2021 |
| 510(k) numbers | K122698 |
| FEI number | 3000718467 |
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