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U.S. Department of Health and Human Services

Class 2 Device Recall XCaliber MetaDiaphyseal Complete Kit

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 Class 2 Device Recall XCaliber MetaDiaphyseal Complete Kitsee related information
Date Initiated by FirmFebruary 22, 2010
Date PostedApril 28, 2010
Recall Status1 Terminated 3 on May 05, 2010
Recall NumberZ-1434-2010
Recall Event ID 55182
510(K)NumberK955848 
Product Classification Pin, fixation, threaded - Product Code JDW
ProductOrthofix US XCaliber Meta-Diaphyseal Complete Kit, Sterile. 99-91600, 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.
Code Information Lot Numbers: IT965408
Recalling Firm/
Manufacturer		 Orthofix Srl
Via Delle Nazioni 9
Bussolengo (Verona) Italy
Manufacturer Reason
for Recall		During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOrthofix 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 Commerce9
DistributionNationwide Distribution -- TX, ND, NY, FL and CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JDW
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