FDA recall Z-1436-2021

Stryker Leibinger GmbH & Co. KG · Class II · device

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

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

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