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Terminated

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 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-1491-2019 · Posted None

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.

K152872K2M Fenestrated Tap SystemK2m · 2016-01-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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