Z-1492-2019Class II

Fenestrated Tap Adapter (REF# 5001-90011)

Name: Z-1492-2019 Fenestrated Tap Adapter (REF# 5001-90011)
Creator: K2M, Inc
Published: 2019-04-18
License: https://open.fda.gov/license/

K2M, Inc / initiated 2019-04-18 / Terminated / root cause: labeling and UDI

FDA source

K2M, Inc began a recall of 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... on 2019-04-18. FDA classified it as Class II and gives the reason as "The products are mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1492-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-18
Posted: 2019-05-25
Terminated: 2020-06-19
Recalling firm: K2M, Inc
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.
Product code: KNW Instrument, Biopsy
Reason for recall: The products are mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by 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.
Quantity in commerce: 462 total
Distribution: The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.
Product codes and lots: All lots in distribution

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1492-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1491-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-25
Z-1492-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-25

Product code KNW

K152872Class IIK2M Fenestrated Tap SystemK2m / cleared 2016-01-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)