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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 62801
Product Type Devices
Status Ongoing
Recalling Firm Encore Medical, Lp
City Austin
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-09
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution including Venezuela.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System. Model Number 392-09-706, Lot Number 59602519 Class II The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired. 7 units Z-2302-2012