“K2M Fenestrated Taps Mislabeled - Product Recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68267-k2m-fenestrated-taps-mislabeled-product-recall. Based on FDA recall #Z-1491-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1491-2019%22&limit=1).
The FDA announced on April 18, 2019, that K2M, Inc. recalled Fenestrated Taps in sizes 4.5mm, 5.5mm, and 6.5mm due to mislabeling hazards. The recall affects all lots distributed to Florida, Kentucky, Michigan, Pennsylvania, South Carolina, and West Virginia.
The products are mislabeled. The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool or to dispense cement during vertebral body augmentation procedures.
Context
GovInfoNow's records show K2M, Inc. has had 10 other recalls on record since July 24, 2018. Other recent recalls of similar products include the Synthes 2.4V Tap Locking Screw Tap Recall (Feb. 25, 2026) and the Centinel Prodisc C SK U.S. Implant Extra Large 5mm - Labeling Mixup Recall (March 20, 2026).
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
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.
Recall number
Product, codes & lots
Z-1491-2019
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.; All lots in distribution
Z-1492-2019
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.; All lots in distribution
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.
Where it went and when
Where it was distributed
Distributed in 6 states.
Listed by the agency
Not listed
FDA distribution: “The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Kentucky, Michigan, Pennsylvania, South Carolina, West Virginia.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.