Conformis, Inc. recalls iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101

Recall date

October 16, 2018

Source

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

Recall number

Z-0731-2019

FDA classification

Class II

Brand / firm

Conformis, Inc.

Sold / distributed

The products were distributed to the following US states: TN.

Why it was recalled

The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.

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 Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101