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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 iUnisee related information
Date Initiated by FirmApril 23, 2009
Date PostedJuly 15, 2009
Recall Status1 Terminated 3 on October 14, 2009
Recall NumberZ-1624-2009
Recall Event ID 51903
510(K)NumberK043570 K063432 K072368 
Product Classification Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
ProductConforMIS iUni ( Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M57220600040. 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 Number : 1853.
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
ActionConforMIS 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 Commerce1 unit
DistributionWorldwide Distribution - US including states of CA, LA, MI and TX and Germany.
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 = HSX
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