Orthofix ISKD Limb Lengthener — Class II medical device recall Z-0895-2013
Terminated recall by Orthofix, Inc, reported 2013-03-06, distributed nationwide. There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, w
| Recall number | Z-0895-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix, Inc, Lewisville, TX, United States |
| Recall initiated | 2012-08-06 |
| Classified | 2013-02-28 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2013-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CH, DE, ES, FI, FR, GR, HK, IL, JP, KR, MX, NL, NZ, SA, SG, TR, ZA |
| Quantity | 1,224 |
| Model numbers | F12-255-305, F12-255-305NS, F12-255-335, F12-255-335NS, F12-300-350, F12-300-350NS, F12-300-380, F12-300-380NS, F12-345-395, F12-345-395NS, F12-345-425, F12-345-425NS, T10-215-265, T10-255-305, T10-255-335, T10-300-350, T12-215-265, T12-215-265NS, T12-245-295, T12-255-305, T12-255-305NS, T12-255-335, T12-255-335NS, T12-300-350, T12-300-350NS and 2 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0895-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.