# FDA recall Z-1436-2021

> **Stryker Leibinger GmbH & Co. KG** · Class II · device recall initiated 2021-04-01.

## 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.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.

## Key facts

- **Recall number:** Z-1436-2021
- **Recalling firm:** Stryker Leibinger GmbH & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-01
- **Report date:** 2021-04-28
- **Termination date:** 2022-12-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Freiburg Im Breisgau, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1436-2021

## Citation

> AI Analytics. FDA recall Z-1436-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1436-2021. Source: US FDA. Licensed CC0.

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