Orthofix ISKD Limb Lengthener Recalled for Potential Post-Operative Failure
Orthofix, Inc. is recalling ISKD limb lengtheners because the device may stop distracting after surgery, potentially causing premature bone consolidation and the need for revision surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (revision surgery) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Orthofix, Inc. is recalling the ISKD (Intramedullary Skeletal Kinetic Distractor) limb lengthener. The device is intended for limb lengthening of the tibia and femur. The recall involves 1,224 units distributed nationwide in the United States and 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.
The recall is being conducted because there is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment. This failure may result in premature bone consolidation, meaning the limb may not achieve the desired length. This outcome could lead to revision surgery to remove and/or replace the device.
The recall covers all serial numbers for specific catalog numbers, including F12-255-305, F12-345-395NS, T12-245-295, and others listed in the agency documentation. Patients and healthcare providers should contact Orthofix, Inc. for further instructions regarding the recall and potential revision procedures.
The recalled product
- Product
- Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.
- Manufacturer
- Orthofix, Inc
- Affected units
- 1,224
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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