Stryker Leibinger GmbH & Co. KG product recalled over mold contamination

Recall date

April 1, 2021

Source

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

Official notice title

Stryker Leibinger GmbH & Co. KG recalls DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer…

Recall number

Z-1436-2021

FDA classification

Class II

Brand / firm

Stryker Leibinger GmbH & Co. KG

Sold / distributed

Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.

Why it was recalled

Inability for the user to inject the paste from the syringe into the target location.

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

What was recalled

DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.