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Conformis, Inc. recalls iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage:
Recalled April 8, 2020 · FDA recall Z-1627-2020 · Conformis
Hazard
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. · FDA Class II
Units
4
Sold at
US Nationwide distribution in the states of LA, NY, TN.
Description
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Product
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR 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.
Manufacturer(s)
Conformis, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →