ConforMIS iTotal Cruciate Retaining Knee Replacement System recalled over labeling errors

Recall date

October 18, 2016

Source

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

Official notice title

ConforMIS, Inc. recalls ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for us…

Recall number

Z-0658-2017

FDA classification

Class II

Brand / firm

ConforMIS, Inc.

Sold / distributed

Distributed to the states of CO and NV.

Why it was recalled

Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.

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 Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. 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.