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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 Kit see related information
Date Initiated by Firm February 22, 2010
Date Posted April 28, 2010
Recall Status1 Terminated 3 on May 05, 2010
Recall Number Z-1434-2010
Recall Event ID 55182
510(K)Number K955848  
Product Classification Pin, fixation, threaded - Product Code JDW
Product Orthofix 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
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 9
Distribution Nationwide Distribution -- TX, ND, NY, FL and CA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JDW and Original Applicant = ORTHOFIX, INC.
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