ConforMIS, Inc. recalls ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intend…

Recall date

October 31, 2016

Source

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

Recall number

Z-0991-2017

FDA classification

Class II

Brand / firm

ConforMIS, Inc.

Sold / distributed

Distribution to TX only

Why it was recalled

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

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

What was recalled

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