Class 2 Device Recall Stryker Radius Spinal System

• Date Initiated by Firm: September 25, 2015
• Create Date: November 12, 2015
• Recall Status: Terminated on July 26, 2016
• Recall Number: Z-0270-2016
• Recall Event ID: 72413
• Product Classification: Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
• Product: Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients.
• Code Information: Catalog #486614530, All Lots
• Recalling Firm/ Manufacturer: Stryker Spine; 2 Pearl Ct; Allendale NJ 07401-1611
• For Additional Information Contact: Nabil Riaz; 201-749-8389
• Manufacturer Reason for Recall: Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does not have an associated 510(k) submisstion and subsequent clearance, which is required as this is a class 2 device.
• FDA Determined Cause: No Marketing Application
• Action: Stryker Spine initiated this recall by sending an "Urgent Product Removal Letter and Product Accountability Form dated September 25, 2015 to the Branch Manager, Agency Manager, Quality Contact via FedEx priority overnight.
• Quantity in Commerce: 42 units
• Distribution: Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NM, NY, OH, OK, OR, PA, TN, TX, UT, WA and WI.
• 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.