Stryker Leibinger GmbH & Co. KG: Medical Device Recall in 2021 - (Recall #: Z-1436-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 1, 2021

Date Posted: April 28, 2021

Recall Number: Z-1436-2021

Event ID: 87684

Reason for Recall:

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

Status: Terminated

Product Quantity: 321 units

Code Information:

Lot: DI20311,DI20307 Product Code (UDI): 07613327123265

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated