Drug recall
Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as…
FDA recall event 82716 · Class II · K2M, Inc
Key facts
| Event ID | 82716 |
|---|---|
| Recall numbers | Z-1491-2019, Z-1492-2019 |
| Recalling firm | K2M, Inc |
| Product type | Devices |
| Products | Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for…, Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The products are mislabeled. |
| Initiation date | Apr 18, 2019 |
| Report date | Jun 5, 2019 |
| Termination date | Jun 19, 2020 |
| 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: