Fenestrated Tap Adapter — Class II medical device recall Z-1492-2019
Terminated recall by K2M, Inc, reported 2019-06-05, distributed in FL, KY, MI, PA, SC, WV. The products are mislabeled.
| Recall number | Z-1492-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | K2M, Inc, Leesburg, VA, United States |
| Recall initiated | 2019-04-18 |
| Classified | 2019-05-25 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2020-06-19 |
| Distributed | FL, KY, MI, PA, SC, WV |
| Quantity | 462 total |
| Reason classes | labeling |
| Model numbers | 5001-90011 |
Product
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 diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
Reason for recall
The products are mislabeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1492-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.