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.
FDA Recall Z-0262-2010 · Posted 2009-11-13
Recalling FirmOrthofix, Inc
Recall StatusTerminated
Product CodeHSB
Date Initiated2009-10-09
Date Terminated2010-09-24
Product Quantity539 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide distribution - In the US: FL, MD, TN, OH, NY, CA, GA. Also Mexico, Italy, Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.