Stryker Corporation: Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a constant high vacuum thr

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: 231 units US; 21 units OUS Lot/code info: GTIN: 04546540055422 Lot Numbers: 22306012 22307012 22340012 22341012 22342012 23017012

UPC codes

04546540055422

Source

Official record: FDA (Device enforcement) ↗

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