Class 2 Device Recall THOR

• Date Initiated by Firm: October 02, 2009
• Date Posted: November 24, 2009
• Recall Status: Terminated on January 23, 2013
• Recall Number: Z-0448-2010
• Recall Event ID: 53606
• 510(K)Number: K073437
• Product Classification: spinal implant component - Product Code KWQ
• Product: Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 49MM, spinal implant component
• Code Information: Catalog number 48036549, all lots
• Recalling Firm/ Manufacturer: Stryker Spine; 2 Pearl Ct; Allendale NJ 07401-1611
• For Additional Information Contact: Ms. Michelle Barry; 201-760-8287
• Manufacturer Reason for Recall: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip.
• FDA Determined Cause: Device Design
• Action: Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.
• Quantity in Commerce: 153
• Distribution: Nationwide
• 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 = KWQ