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U.S. Department of Health and Human Services

Class 2 Device Recall Tournier Arthro Tunneler

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  Class 2 Device Recall Tournier Arthro Tunneler see related information
Date Initiated by Firm December 04, 2009
Date Posted January 19, 2010
Recall Status1 Terminated 3 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 2		 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.
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