Z-0262-2010

Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a...

Name: Z-0262-2010 Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a...
Creator: Orthofix, Inc
Published: 2009-10-09
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2009-10-09 / Terminated

FDA source

Orthofix, Inc began a recall of Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a telescoping Internal Limb Lengthener, Locking Screws... on 2009-10-09. The reason FDA records is "ISKD lengthening device has the potential for not pre-distracting. This may cause or contribute to device malfunction, and if not discovered prior to use, may require surgical re-intervention or removal". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0262-2010
Status: Terminated
Initiated: 2009-10-09
Posted: 2009-11-13
Terminated: 2010-09-24
Recalling firm: Orthofix SRL
Product: Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a telescoping Internal Limb Lengthener, Locking Screws, Instrumentation and an external hand-held Monitor; catalog numbers: T10-215-265, T10-215-265NS, T10-255-305, T10-255-305NS, T10-255-335, T10-300-350, T10-300-350NS, T12-215-265, T12-245-295, T12-255-305, T12-255-305NS, T12-255-335, T12-300-350, T12-380-380, 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, and F12-345-425NS.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: ISKD lengthening device has the potential for not pre-distracting. This may cause or contribute to device malfunction, and if not discovered prior to use, may require surgical re-intervention or removal.
FDA root cause: Other
Action: Firm notified consignees by letter sent via certified mail on 10/9/2009. Follow up is planned for nonresponders. Questions are directed to the firm at (800) 527-0404.
Quantity in commerce: 539 units
Distribution: Worldwide distribution - In the US: FL, MD, TN, OH, NY, CA, GA. Also Mexico, Italy, Canada.
Product codes and lots: All lot and serial numbers are being recalled.

Product code HSB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)