Orthofix, Inc: Medical Device Recall in 2013 - (Recall #: Z-0895-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.

Product Classification:

Class II

Date Initiated: August 6, 2012

Date Posted: March 6, 2013

Recall Number: Z-0895-2013

Event ID: 62804

Reason for Recall:

There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device.

Status: Terminated

Product Quantity: 1224

Code Information:

All serial numbers of the following Catalog Numbers: F12-255-305, F12-345-395NS, T12-245-295, F12-255-305NS, F12-345-425, T12-255-305, F12-255-335, F12-345-425NS, T12-255-305NS, F12-255-335NS, T10-215-265, T12-255-335, F12-300-350, T10-255-305, T12-255-335NS, F12-300-350NS, T10-255-335, T12-300-350, F12-300-380, T10-300-350, T12-300-350NS, F12-300-380NS, T12-215-265, T12-300-380, F12-345-395, T12-215-265NS, and T12-300-380NS

Distribution Pattern:

Worldwide Distribution - USA (nationwide) Internationally to Australia, Hong Kong, Saudi Arabia, Korea, Turkey, Greece, Finland, South Africa, Spain, Singapore, Switzerland, Brazil, Germany, France, Japan, Netherlands, New Zealand, Israel, Canada and Mexico

Voluntary or Mandated:

Voluntary: Firm initiated