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U.S. Department of Health and Human Services

Class 2 Device Recall ConforMIS iUni

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  Class 2 Device Recall ConforMIS iUni see related information
Date Initiated by Firm April 23, 2009
Date Posted July 15, 2009
Recall Status1 Terminated 3 on October 14, 2009
Recall Number Z-1623-2009
Recall Event ID 51903
510(K)Number K043570  K063432  K072368  
Product Classification Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
Product ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M57220600020.

For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component.
Code Information Serial Numbers: 2571, 2706, 1755, 2665, 1757 and 2749. 
Recalling Firm/
Manufacturer		 Conformis Inc
2 Forth Ave
Burlington MA 01803
Manufacturer Reason
for Recall		 Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
FDA Determined
Cause 2		 Process control
Action ConforMIS contacted accounts and presented the surgeon with the customer communication letter dated April 23, 2009, customized for the surgeon by serial number and patient identification. Product not yet implanted will be recovered. A patient evaluation and monitoring protocol will be recommended for potentially affected product already implanted. Contact ConforMIS for further questions at 1-781-345-9164.
Quantity in Commerce 6 units
Distribution Worldwide Distribution - US including states of CA, LA, MI and TX and Germany.
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 = HSX and Original Applicant = CONFORMIS, INC.
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