Conformis, Inc. recalls iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The…

Recall date

February 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1628-2020

FDA classification

Class II

Brand / firm

Conformis, Inc.

Sold / distributed

US Nationwide distribution in the states of LA, NY, TN.

Why it was recalled

A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.