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.
Reported: April 28, 2021 Initiated: April 1, 2021 #Z-1436-2021
Product 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 for Recall
Inability for the user to inject the paste from the syringe into the target location.
Details
- Recalling Firm
- Stryker Leibinger GmbH & Co. KG
- Units Affected
- 321 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
- Location
- Freiburg Im Breisgau, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Leibinger GmbH & Co. KG. Units affected: 321 units.
Why was this product recalled? ▼
Inability for the user to inject the paste from the syringe into the target location.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 28, 2021. Severity: Moderate. Recall number: Z-1436-2021.
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