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.
FDA Recall Z-1492-2019 · Posted None
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Recalling FirmK2M, Inc
Recall StatusTerminated
Product CodeKNW
Date Initiated2019-04-18
Date Terminated2020-06-19
Product Quantity462 total
Reason for Recall
The products are mislabeled.
Firm Action
Urgent Medical Device Recall notification letters dated 4/18/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions contact the Regulatory Compliance Team:
[email protected] or 201.749.8090.
Root Cause
Under Investigation by firm
Distribution Pattern
The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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