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U.S. Department of Health and Human Services

Class 2 Device Recall Orthofix ISKD Limb Lengthener Sterile Rx Only

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  Class 2 Device Recall Orthofix ISKD Limb Lengthener Sterile Rx Only see related information
Date Initiated by Firm August 06, 2012
Date Posted February 28, 2013
Recall Status1 Terminated 3 on May 17, 2013
Recall Number Z-0895-2013
Recall Event ID 62804
510(K)Number K010322  K031219  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor.

The ISKD is intended for limb lengthening of the tibia and femur.
Code Information All serial numbers of the following Catalog Numbers: F12-255-305, F12-345-395NS, T12-245-295, F12-255-305NS, F12-345-425, T12-255-305, F12-255-335, F12-345-425NS, T12-255-305NS, F12-255-335NS, T10-215-265, T12-255-335, F12-300-350, T10-255-305, T12-255-335NS, F12-300-350NS, T10-255-335, T12-300-350, F12-300-380, T10-300-350, T12-300-350NS, F12-300-380NS, T12-215-265, T12-300-380, F12-345-395, T12-215-265NS, and T12-300-380NS
Recalling Firm/
Orthofix, Inc
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information Contact Diana Easton
Manufacturer Reason
for Recall
There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Orthofix sent an Urgent Product Recall Notification letter dated August 6, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue distribution of devices, identify the affected and remove from their inventory, and returned to the firm. Credit will be issued upon receipt of the returned product. Customers were asked to take the actions listed in the enclosed Product Return Instructions immediately. Customers with questions should contact Orthofix Customers Service by telephone at 800-266-3349 or 214-937-2047. For questions regarding this recall call 214-937-2509.
Quantity in Commerce 1224
Distribution Worldwide Distribution - USA (nationwide) Internationally to Australia, Hong Kong, Saudi Arabia, Korea, Turkey, Greece, Finland, South Africa, Spain, Singapore, Switzerland, Brazil, Germany, France, Japan, Netherlands, New Zealand, Israel, Canada and Mexico
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.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = ORTHODYNE, INC.
510(K)s with Product Code = HSB and Original Applicant = ORTHOFIX, INC.