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.
FDA Recall Z-1435-2010 · Posted 2010-04-28
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Recalling FirmOrthofix Srl
Recall StatusTerminated
Product CodeJDW
Date Initiated2010-02-22
Date Terminated2010-05-05
Product Quantity25
Reason for Recall
During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution -- TX, ND, NY, FL and CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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