Stryker Leibinger GmbH & Co. KG Recall 87684
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.
Stryker Leibinger GmbH & Co. KG Recall 87684 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1436-2021 |
| Event ID | 87684 |
| Event 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 Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan. |
| Quantity | 321 units |
| Recall Reason | Inability for the user to inject the paste from the syringe into the target location. |
| Device Classification | 20210428 |
| Device Code Info | Lot: DI20311,DI20307 Product Code (UDI): 07613327123265 |
| Center Classification Date | 20210419 |
| Recall Initiation Date | 20210401 |
| Recalling Firm | Stryker Leibinger GmbH & Co. KG |
| Initial Notification | Letter |
| Similar To |