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.
- Company
- Orthofix, Inc
- Recall Initiated
- October 9, 2009
- Posted
- November 13, 2009
- Terminated
- September 24, 2010
- Recall Number
- Z-0262-2010
- Quantity
- 539 units
- Firm Location
- McKinney, TX
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.
Distribution
Worldwide distribution - In the US: FL, MD, TN, OH, NY, CA, GA. Also Mexico, Italy, Canada.
Lot / Code Info
All lot and serial numbers are being recalled.
Root Cause
Other
Action Taken
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.