Device product
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.
Z-2596-2023
Product summary
- Event
- Event 92841
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 109 units US; 290 units OUS
- Official record key
device-enforcement:Z-2596-2023
Official wording
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
Code information: GTIN: 04546540039415 Lot Numbers: 22314012 22336012
Distribution pattern: Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK
Derived failure modes
-
Unknown
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