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

Recalled April 28, 2021 · FDA recall Z-1436-2021 · Stryker Leibinger GmbH & Co. KG

Hazard

Inability for the user to inject the paste from the syringe into the target location. · FDA Class II

Units

321 units

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Stryker Leibinger GmbH & Co. KG

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →