Stryker Corporation Recall 92841
Description: Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.
Stryker Corporation Recall 92841 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2596-2023 |
| Event ID | 92841 |
| Event Description | Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000. |
| Product Type | Devices |
| Distribution | Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK |
| Quantity | 109 units US; 290 units OUS |
| Recall Reason | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site |
| Device Classification | 20230927 |
| Device Code Info | GTIN: 04546540039415 Lot Numbers: 22314012 22336012 |
| Center Classification Date | 20230918 |
| Recall Initiation Date | 20230807 |
| Recalling Firm | Stryker Corporation |
| Initial Notification | Letter |
| Similar To |