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.
FDA Recall Z-1436-2021 · Posted None
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Recalling FirmStryker Leibinger GmbH & Co. KG
Recall StatusTerminated
Product CodeGXP
Date Initiated2021-04-01
Date Terminated2022-12-19
Product Quantity321 units
Reason for Recall
Inability for the user to inject the paste from the syringe into the target location.
Firm Action
On 04/01/2021, Stryker issued an Urgent Medical Device Removal notice via letter informing customers that users have reported the inability to push the paste through the Mixer-Cannula which prohibits the injection into a bone void.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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