FDA Recall
Terminated
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.
Recall: Z-1436-2021
·
Initiated April 1, 2021
Recall
- Recall Number
- Z-1436-2021
- Event Number
- 87684
- Firm
- Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany
- FEI Number
- 3002821504
- Product Code
- GXP
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 1, 2021
- Terminated
- December 19, 2022
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.
Reason
Inability for the user to inject the paste from the syringe into the target location.
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.
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
Quantity
321 units