Conformis, Inc. recalls iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102

Recall date

January 4, 2019

Source

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

Recall number

Z-1079-2019

FDA classification

Class II

Brand / firm

Conformis, Inc.

Sold / distributed

The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany

Why it was recalled

The labeling of the boxes and sterile pouches did not match the contents.

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 Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102