Class 2 Device Recall ArthroCare Knot Pusher

• Date Initiated by Firm: December 09, 2013
• Date Posted: January 09, 2014
• Recall Status: Terminated on April 08, 2015
• Recall Number: Z-0652-2014
• Recall Event ID: 67087
• Product Classification: orthopedic manual surgical instrument - Product Code LXH
• Product: Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
• Code Information: Catalog #25-3011, Lot #1049402
• Recalling Firm/ Manufacturer: ArthroCare Medical Corporation; 7000 W William Cannon Dr; Austin TX 78735-8509
• For Additional Information Contact: 800-797-6520 Ext. 2
• Manufacturer Reason for Recall: A sharp edge on the cannulated tip of the device may damage or cut a suture.
• FDA Determined Cause: Nonconforming Material/Component
• Action: All consignees were provided with written notice via Urgent Recall Notification dated December 9, 2013 with delivery confirmation. In addition, the firm plans on notifying the EU, and the governments of France, Germany, Switzerland, and Spain. The firm will also notify the Swedish government because the firm's EU representative is located in Sweden.
• Quantity in Commerce: 76
• Distribution: Worldwide distribution: US (nationwide) including states of: CA, FL, GA, IL, IN, KY, MN, MO, NY, OH, TX, and WI. Internationally to: Canada, France, Germany, Spain, and Switzerland.
• 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.