Drug recall
Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C…
FDA recall event 84033 · Class II · Tornier, Inc
Key facts
| Event ID | 84033 |
|---|---|
| Recall numbers | Z-0405-2020 |
| Recalling firm | Tornier, Inc |
| Product type | Devices |
| Products | Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the… |
| Initiation date | Oct 18, 2019 |
| Report date | Nov 20, 2019 |
| Termination date | Apr 9, 2021 |
| City | Bloomington |
| State | MN |
| Country | United States |
| FEI number | 3000718467 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: