FDA Device recall Z-1436-2021
DirectInject consists of a sterile dual paste system which is calcium phosphate based
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of DirectInject consists of a sterile dual paste system which is calcium phosphate based by Stryker Leibinger And Kg, citing inability for the user to inject the paste from the syringe into the target location.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1436-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-01 |
| Published | 2021-04-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Leibinger And Kg |
| Distribution | US |
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.
Reason
Inability for the user to inject the paste from the syringe into the target location.
Identifiers
| code_info | Lot: DI20311,DI20307 Product Code (UDI): 07613327123265 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1436-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.