IMPLANTCAST GMBH recalls EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole c…

Recall date

May 10, 2021

Source

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

Recall number

Z-2050-2021

FDA classification

Class II

Brand / firm

IMPLANTCAST GMBH

Sold / distributed

U.S. Nationwide distribution in the states of FL and TX.

Why it was recalled

A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factor.

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

What was recalled

EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless 52mm dia incl. central hole cover; 02200054 /EcoFit cup cementless 54mm dia incl. central hole cover; 02200056 /EcoFit cup cementless 56mm dia incl. central hole cover; 02200058 /EcoFit cup cementless 58mm dia incl. central hole cover; 02200060 /EcoFit cup cementless 60mm dia incl. central hole cover; 02200062 /EcoFit cup cementless 62mm dia incl. central hole cover; 02200064 /EcoFit cup cementless 64mm dia incl. central hole cover; 02200066 /EcoFit cup cementless 66mm dia incl. central hole cover; 02200068 /EcoFit cup cementless 68mm dia incl. central hole cover;