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U.S. Department of Health and Human Services

Class 2 Device Recall External Bone Fixation System

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 Class 2 Recall
External Bone Fixation System
see related information
Date Posted February 26, 2008
Recall Status1 Terminated on March 20, 2008
Recall Number Z-0674-2008
Recall Event ID 45878
Premarket Notification
510(K) Number
K941048 
Product Classification Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite - Product Code LXT
Product Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150mm (Catalog Number: 50-1015) and 200mm (Catalog Number: 50-1016), distributed by Orthofix, Inc., McKinney, TX 75069.
Code Information Lot numbers: For Catalog #50-1101 (75mm): 075; For Catalog #50-1014 (100mm): 7241, 076 and 50826; For Catalog #50-1015 (150mm): 2664-01, 7343 and 080; For Catalog #50-1016 (200mm): 145, 7342 and 068.
Recalling Firm/
Manufacturer
Orthofix, Inc
1720 Bray Central Dr
Mckinney, Texas 75069-8207
Manufacturer Reason
for Recall
Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.
Quantity in Commerce 69 units.
Distribution Nationwide Distribution - USA states: CA, FL, GA, IL, PA, MI, NY and WI.
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.
510(K) Database 510(K)s with Product Code = LXT and Original Applicant = APPLIED OSTEO SYSTEMS, INC.
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