Home / Recalls / ConforMIS, Inc. / Z-0991-2017

Z-0991-2017 Class II Terminated

Recalled by ConforMIS, Inc. — Bedford, MA

Recall Details

Product Type
Devices
Report Date
January 18, 2017
Initiation Date
October 31, 2016
Termination Date
January 11, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System 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, patellofemoral or bicompartmental prosthesis

Reason for Recall

iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).

Distribution Pattern

Distribution to TX only

Code Information

Serial Number: 0384180

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