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.
This recall has been terminated (originally issued April 1, 2021).
- Recall Initiated
- April 1, 2021
- Terminated
- December 19, 2022
- Recall Number
- Z-1436-2021
- Quantity
- 321 units
- Official Source
- View on FDA website ↗
Reason for Recall
Inability for the user to inject the paste from the syringe into the target location.
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
Lot / Code Info
Lot: DI20311,DI20307 Product Code (UDI): 07613327123265
Root Cause
Under Investigation by firm
Action Taken
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.
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