Stryker Corporation: Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high vacuum through the process Ca

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: 224 units US; 718 units OUS Lot/code info: GTIN: 04546540857880 Lot Numbers: 22332012 22336012 22333012 22355012 23052012

UPC codes

04546540857880

Source

Official record: FDA (Device enforcement) ↗

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