K2M, Inc recalls Everest MI XT Inner Dilator, Catalog Number 5101-90167

Recall date

January 13, 2022

Source

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

Recall number

Z-0705-2022

FDA classification

Class II

Brand / firm

K2M, Inc

Sold / distributed

Worldwide distribution - US Nationwide.

Why it was recalled

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

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

What was recalled

Everest MI XT Inner Dilator, Catalog Number 5101-90167