Class 2 Device Recall YUKON OCT Spinal System

• Date Initiated by Firm: December 14, 2020
• Date Posted: January 27, 2021
• Recall Status: Terminated on July 11, 2023
• Recall Number: Z-0931-2021
• Recall Event ID: 87075
• 510(K)Number: K171444
• Product Classification: Posterior cervical screw system - Product Code NKG
• Product: Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
• Code Information: Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582
• Recalling Firm/ Manufacturer: K2M, Inc; 600 Hope Pkwy SE; Leesburg VA 20175-4428
• For Additional Information Contact: Ms. Margarita Karan; 201-749-8389
• Manufacturer 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).
• FDA Determined Cause: Employee error
• Action: On 12/14/2020, Stryker Spine US Field Operations were notified of the action by teleconference and e-mail and instructed to identify and return all Lot KRBX screws to Stryker Spine. Affected Stryker Branches/Agencies, and hospitals that had previously been consigned product, will be issued a formal recall notification letter and product return documentation.
• Quantity in Commerce: 248 units/1 each
• Distribution: Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
• 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