medical Class II Updated 2023-09-27

Stryker Corporation recalls Stryker ACM (Advanced Cement Mixing) System: Break-Away Fem

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 04546540039415 Lot Numbers: 22314012 22336012
View official government recall

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