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Conformis, Inc. recalls iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The
Recalled April 8, 2020 · FDA recall Z-1628-2020 · 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
2
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 PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY 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 →