FDA Enforcement
Class II
Ongoing
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000
Recall: Z-2599-2023
·
Reported September 27, 2023
Enforcement
- Recall Number
- Z-2599-2023
- Event ID
- 92841
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 27, 2023
- Initiation Date
- August 7, 2023
- Classification Date
- September 18, 2023
- Address
- 1941 Stryker Way, Portage, MI, 49002-9711, United States
Description
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000
Reason
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
Code Info
GTIN: 04546540899071 Lot Numbers: 22305012 22336012
Distribution
Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK
Quantity
8 units US