CLASS II Device recall · Reported 5 Jun 2019 · FDA Enforcement Report

Fenestrated Tap Adapter recalled by K2M

K2M is recalling Fenestrated Tap Adapter (, distributed in Florida, Kentucky, Michigan, Pennsylvania, South Carolina, West Virginia. The recall was initiated on 18 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots in distribution

Quantity recalled462 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1492-2019
FDA event ID: 82716
Recalling firm: K2M, Leesburg, VA
Classification: Class II
Status: Terminated
Recall initiated: 18 Apr 2019
FDA classified: 25 May 2019
Reported: 5 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Spinal Implants

Timeline

18 Apr 2019	Recall initiated by company
25 May 2019	Classified by FDA	+37 days
5 Jun 2019	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The products are mislabeled.

Product as listed by the FDA

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.

Where it was distributed

The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.

Florida Kentucky Michigan Pennsylvania South Carolina West Virginia

Questions about this recall

Is Fenestrated Tap Adapter ( recalled?

Yes. K2M recalled Fenestrated Tap Adapter ( on 18 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1492-2019.

Why was it recalled?

The products are mislabeled.

Which lots are affected?

All lots in distribution

Where was it sold?

The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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