Reported Feb 3, 2021 · Terminated

Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System

K2M, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: K2M, Inc · 600 Hope Pkwy SE · Leesburg, VA · 20175-4428

Is this the product you have?

  • Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Lot codes and dates
  • Product Name / Catalog Number7601-04026
  • Serial/Lot Number(s) AffectedLot
  • KRBX Product Code (UDI)10888857349582
Amount recalled
248 units/1 each

Where it was sold

  • Nationwide

Why it was recalled

The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 11, 2023 · Data as of Sep 19, 7:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.