Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. Recalled by Orthofix, Inc Due to There is a possibility that the ISKD limb...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Orthofix, Inc directly.
Affected Products
Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.
Quantity: 1224
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Orthofix, Inc
Orthofix, Inc has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report