Recall Z-0520-2021— K2M, Inc

Name: FDA recall Z-0520-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-03

Class II · Terminated

Class II FDA medical device recall by K2M, Inc, initiated 2020-11-03, terminated 2021-01-12. It names one FDA 510(k) clearance: K193129. 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: 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..

Recalling firm: K2M, Inc
Classification: Class II
Status: Terminated
Initiated: 2020-11-03
Terminated: 2021-01-12
Firm location: Leesburg, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K193129 — Yukon OCT Spinal SystemK2m, Inc.·cleared 2020-02-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.