Stryker Corporation: 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 proc

Hazard

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

Details from the source

Reason for recall: 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 Distribution: Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK Quantity: 652 units US; 1607 units OUS Lot/code info: GTIN: 04546540055415 Lot Numbers: 22313012 22314012 22315012 22343012 22348012 22349012 22350012 22353012

UPC codes

04546540055415

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.