Home / Recalls / K2M, Inc / Z-0931-2021

Z-0931-2021 Class II Terminated

Recalled by K2M, Inc — Leesburg, VA

Recall Details

Product Type
Devices
Report Date
February 3, 2021
Initiation Date
December 14, 2020
Termination Date
July 11, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
248 units/1 each

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).

Distribution Pattern

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

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