Recall Z-1436-2021— Stryker Leibinger GmbH & Co. KG
Class II · Terminated
Class II FDA medical device recall by Stryker Leibinger GmbH & Co. KG, initiated 2021-04-01, terminated 2022-12-19. It names one FDA 510(k) clearance: K143661. 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..
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-01
- Terminated
- 2022-12-19
- Firm location
- Freiburg Im Breisgau, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.