medical Class II Updated 2023-09-27

Stryker Corporation recalls Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femo

Recalled Product

Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000


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: 04546540055415 Lot Numbers: 22313012 22314012 22315012 22343012 22348012 22349012 22350012 22353012
View official government recall

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