Z-1436-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 28, 2021
- Initiation Date
- April 1, 2021
- Termination Date
- December 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 321 units
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
Code Information
Lot: DI20311,DI20307 Product Code (UDI): 07613327123265