FDA recall Z-0520-2021

K2M, Inc · Class II · device

Product

Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.

Reason for recall

Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2020-11-03
Report date
2020-12-09
Termination date
2021-01-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Leesburg, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0520-2021