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U.S. Department of Health and Human Services

Class 2 Device Recall Intramedullary Skeletal Kinetic Distractor (ISKD)

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  Class 2 Device Recall Intramedullary Skeletal Kinetic Distractor (ISKD) see related information
Date Initiated by Firm October 09, 2009
Date Posted November 13, 2009
Recall Status1 Terminated 3 on September 24, 2010
Recall Number Z-0262-2010
Recall Event ID 53578
Product Classification Limb Lengthener - Product Code HSB
Product Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a telescoping Internal Limb Lengthener, Locking Screws, Instrumentation and an external hand-held Monitor; catalog numbers: T10-215-265, T10-215-265NS, T10-255-305, T10-255-305NS, T10-255-335, T10-300-350, T10-300-350NS, T12-215-265, T12-245-295, T12-255-305, T12-255-305NS, T12-255-335, T12-300-350, T12-380-380, F12-255-305, F12-255-305NS, F12-255-335, F12-255-335NS, F12-300-350, F12-300-350NS, F12-300-380, F12-300-380NS, F12-345-395, F12-345-395NS, F12-345-425, and F12-345-425NS.
Code Information All lot and serial numbers are being recalled.
Recalling Firm/
Manufacturer		 Orthofix, Inc
1720 Bray Central Dr
McKinney TX 75069-8207
For Additional Information Contact
469-742-2500
Manufacturer Reason
for Recall		 ISKD lengthening device has the potential for not pre-distracting. This may cause or contribute to device malfunction, and if not discovered prior to use, may require surgical re-intervention or removal.
FDA Determined
Cause 2		 Other
Action Firm notified consignees by letter sent via certified mail on 10/9/2009. Follow up is planned for nonresponders. Questions are directed to the firm at (800) 527-0404.
Quantity in Commerce 539 units
Distribution Worldwide distribution - In the US: FL, MD, TN, OH, NY, CA, GA. Also Mexico, Italy, Canada.
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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