Recall Z-0895-2013— Orthofix, Inc
Class II · Terminated
Class II FDA medical device recall by Orthofix, Inc, initiated 2012-08-06, terminated 2013-05-17. It names 2 FDA 510(k) clearances: K031219, K010322. Product: Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.. Reason: 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..
- Recalling firm
- Orthofix, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-06
- Terminated
- 2013-05-17
- Firm location
- Lewisville, TX, United States
510(k) clearances named in this recall
2 on FDA's record- K031219 — MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
- K010322 — ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.