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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 Recall
Tournier Arthro Tunneler
see related information
Date Posted January 19, 2010
Recall Status1 Open
Recall Number Z-0656-2010
Recall Event ID 54036
Product Classification Accessories,Arthroscopic - 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
Manufacturer Reason
for Recall
Device failed to deploy the distal loop
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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