Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
FDA Recall #Z-0931-2021 — Class II — December 14, 2020
Product Description
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
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).
Recalling Firm
K2M, Inc — Leesburg, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
248 units/1 each
Distribution
Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
Code Information
Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated