Z-1435-2010

Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. manufactured by Orthofix SRL, Via delle Nazioni...

Name: Z-1435-2010 Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. manufactured by Orthofix SRL, Via delle Nazioni...
Creator: Orthofix Srl
Published: 2010-02-22
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2010-02-22 / Terminated / root cause: manufacturing process

FDA source

Orthofix Srl began a recall of Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy. Intended for use... on 2010-02-22. The reason FDA records is "During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1435-2010
Status: Terminated
Initiated: 2010-02-22
Posted: 2010-04-28
Terminated: 2010-05-05
Recalling firm: Orthofix SRL
Product: Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy. Intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
Product code: JDW Pin, Fixation, Threaded
Reason for recall: During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Orthofix issued an "Urgent: Field Safety Notice" dated February 22, 2010. Consignees were informed of the affected product and instructed to cease use and to return the product to the firm.
Quantity in commerce: 25
Distribution: Nationwide Distribution -- TX, ND, NY, FL and CA.
Product codes and lots: Lot Numbers: IT956155 and IT967331

Product code JDW

K955848Class IIOrthofix ModulsystemOrthofix, Inc. / cleared 1996-03-20

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)