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Recall Observatory FDA recall evidence

Device 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.

Z-1436-2021

April 01, 2021

Class II

Product summary

Firm
Stryker Leibinger GmbH & Co. KG
Event
Event 87684
Status
Terminated
Classification
Class II
Quantity
321 units
Official record key
device-enforcement:Z-1436-2021

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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