Drug recall
Everest MI XT Inner Dilator, Catalog Number 5101-90167
FDA recall event 89522 · Class II · K2M, Inc
Key facts
| Event ID | 89522 |
|---|---|
| Recall numbers | Z-0705-2022, Z-0706-2022 |
| Recalling firm | K2M, Inc |
| Product type | Devices |
| Products | Everest MI XT Inner Dilator, Catalog Number 5101-90167, Everest MI XT Outer Dilator, Catalog Number 5101-90168 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other… |
| Initiation date | Jan 13, 2022 |
| Report date | Mar 9, 2022 |
| City | Leesburg |
| State | VA |
| Country | United States |
| FEI number | 3008599177 |
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: