Class 2 Device Recall Tournier Arthro Tunneler

• Date Initiated by Firm: December 04, 2009
• Date Posted: January 19, 2010
• Recall Status: Terminated on February 29, 2016
• Recall Number: Z-0656-2010
• Recall Event ID: 54036
• Product Classification: arthroscopic instrument - Product Code NBH
• Product: Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101
• Code Information: Lot Numbers: 09K1, 09J5, 09J6, 09K3, 09K4, & 09K5
• Recalling Firm/ Manufacturer: TAG Medical Corp.; Kibbutz Gaaton; Naharia Israel
• Manufacturer Reason for Recall: Device failed to deploy the distal loop
• FDA Determined Cause: Process change control
• Action: Medicsense, the US Agent notified the sole distributor Tornier Inc., Edina, MN of the recall and requested notification to users requesting to discontinue and return product. Letter to customers dated December 4, 2009.
• Quantity in Commerce: 60 UNITS
• 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.