Recall Z-0262-2010 ยท HSB Rod, Fixation, Intramedullary And Accessories
Orthofix, Inc
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, T12-300-3
| Date | Nov 13, 2009 (initiated Oct 9, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 539 units |
| Distribution | Worldwide distribution - In the US: FL, MD, TN, OH, NY, CA, GA. Also Mexico, Italy, Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.