Class 2 Device Recall Yukon AntiTorque Alignment Tube

• Date Initiated by Firm: November 03, 2020
• Create Date: December 02, 2020
• Recall Status: Terminated on January 12, 2021
• Recall Number: Z-0520-2021
• Recall Event ID: 86748
• 510(K)Number: K193129
• Product Classification: Posterior cervical screw system - Product Code NKG
• 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.
• Code Information: Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948
• FEI Number: 3008599177
• Recalling Firm/ Manufacturer: K2M, Inc; 600 Hope Pkwy SE; Leesburg VA 20175-4428
• For Additional Information Contact: Maragrita Karan; 201-749-8389
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Our records indicate Stryker previously distributed catalog no. 7601-9001, Lot KTGG to your location in a Stryker Loaner Set. The nonconforming instrument was subsequently identified and quarantined during routine processing of loaner sets by Stryker at its Leesburg facility. This communication is being made for notification purposes only. The only action requested of you is to complete the Business Reply form found on the following page and return it to the email addresses referenced in the form. If you have any questions or concerns, please contact Stryker Regulatory Compliance at 201-749-8090. On behalf of Stryker we thank you sincerely for your help and support in completing the Business Reply Form and returning it to Stryker by November 6th, 2020.
• Quantity in Commerce: 4 devices
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NKG