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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis.
Recall Number Z-2222-2012
Classification Class II
Code Info All serial numbers
Product Distributed Qty 1427 units
Reason For Recall Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique

Event Detail

Event Id 62576
Product Type Devices
Status Ongoing
Recalling Firm Conformis Inc
City Burlington
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US Nationwide and the country of Germany