K2M Fenestrated Taps Mislabeled - Product Recall

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Recalling firmK2M, Inc600 Hope Pkwy SE, N/A · Leesburg, VA 20175-4428

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✎ GovInfoNow plain-language explainer

What happened, in plain English

K2M is recalling its Fenestrated Taps (4.5mm, 5.5mm, 6.5mm) because they are mislabeled. This issue means users might not know which model they have, potentially causing confusion in medical procedures.

Why it’s dangerous

Mislabeled taps could lead to incorrect model selection during spinal procedures. This might cause improper bone sample removal or cement delivery, affecting surgical outcomes.

Who’s affected

Medical professionals using K2M Fenestrated Taps for spinal procedures are likely affected. Patients undergoing vertebroplasty procedures may be at risk if the wrong tap is used.

How to tell if you have this one

Check for model numbers 4.5mm, 5.5mm, or 6.5mm with reference numbers 5001-90013, 5001-90014, or 5001-90015. All distributed lots are affected.

Brand
K2M
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Labels
Look for model numbers 4.5mm, 5.5mm, or 6.5mm with reference numbers 5001-90013, 5001-90014, or 5001-90015.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The K2M Fenestrated Taps are mislabeled, which could lead to incorrect model selection during spinal procedures.

What models are affected?

Fenestrated Taps 4.5mm, 5.5mm, and 6.5mm with reference numbers 5001-90013, 5001-90014, and 5001-90015.

Do I need to stop using these taps?

The recall does not specify a stop-use action; check labels to confirm if you have the affected models.

Take action

Contact K2M

We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1491-2019 — K2M K2M

Hello,

I own a K2M that is covered by recall Z-1491-2019 from K2M.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1491-2019 (April 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1491-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

K2M, Inc recalls Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap

Recall notice