Reported Mar 6, 2013 · Terminated
Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb…
Orthofix, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix, Inc · 3451 Plano Pkwy · Lewisville, TX · 75056-9453
Is this the product you have?
- Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.
- Lot codes and dates
- All serial numbers
- of the following Catalog Numbers
F12-255-305F12-345-395NST12-245-295F12-255-305NSF12-345-425T12-255-305F12-255-335F12-345-425NST12-255-305NSF12-255-335NST10-215-265T12-255-335F12-300-350T10-255-305T12-255-335NSF12-300-350NST10-255-335T12-300-350F12-300-380T10-300-350T12-300-350NSF12-300-380NST12-215-265T12-300-380F12-345-395T12-215-265NSand T12-300-380NS
- Amount recalled
- 1224
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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