DirectInject consists of a sterile dual paste system which is calcium… — Class II medical device recall Z-1436-2021
Terminated recall by Stryker Leibinger GmbH & Co. KG, reported 2021-04-28, distributed nationwide. Inability for the user to inject the paste from the syringe into the target location.
| Recall number | Z-1436-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Leibinger GmbH & Co. KG, Freiburg Im Breisgau, N/A, Germany |
| Recall initiated | 2021-04-01 |
| Classified | 2021-04-19 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2022-12-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DE, FR, IT, JP |
| Quantity | 321 units |
| UPC / GTIN / UDI-DI | 07613327123265 |
| Lot numbers | DI20307, DI20311 |
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 for recall
Inability for the user to inject the paste from the syringe into the target location.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1436-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.