FDA recall Z-0931-2021

K2M, Inc · Class II · device

Product

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

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

Key facts

Status
Terminated
Initiation date
2020-12-14
Report date
2021-02-03
Termination date
2023-07-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Leesburg, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0931-2021