Z-2602-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2023
- Initiation Date
- August 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 231 units US; 21 units OUS
Product Description
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 through the process. Catalog Number: 0306-705-000
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 Pattern
Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK
Code Information
GTIN: 04546540055422 Lot Numbers: 22306012 22307012 22340012 22341012 22342012 23017012