Devices

Intramedullary Skeletal Kinetic Distractor (ISKD)

Model / Serial
All lot and serial numbers are being recalled.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution - In the US: FL, MD, TN, OH, NY, CA, GA. Also Mexico, Italy, Canada.
Product Description
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.
Manufacturer
Orthofix, Inc
1 Event
- Recall of Intramedullary Skeletal Kinetic Distractor (ISKD)

Manufacturer

Orthofix, Inc

Manufacturer Address
Orthofix, Inc, 1720 Bray Central Dr, McKinney TX 75069-8207
Manufacturer Parent Company (2017)
Orthofix International Nv
Source
USFDA

One device with a similar name

Learn more about the data here

Orthofix Intramedullary Skeletal Kinetic Distractor (ISKD)

Model / Serial
Model: 33 models, Affected: All serial numbers
Manufacturer
Orthofix Srl

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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