K2M, Inc: Medical Device Recall in 2021 - (Recall #: Z-0931-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 14, 2020

Date Posted: February 3, 2021

Recall Number: Z-0931-2021

Event ID: 87075

Reason for Recall:

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

Status: Terminated

Product Quantity: 248 units/1 each

Code Information:

Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582

Distribution Pattern:

Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore

Voluntary or Mandated:

Voluntary: Firm initiated