Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user ...
FDA Recall #Z-2598-2023 — Class II — August 7, 2023
Product Description
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000
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
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5155 units US; 1607 units OUS
Distribution
Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK
Code Information
GTIN: 04546540055408 Lot Numbers: 22305012 22306012 22307012 22308012 22311012 22315012 22316012 22318012 22319012 22320012 22321012 22322012 22323012 22325012 22326012 22327012 22332012 22333012 22334012 22335012 22336012 22337012 22340012 22341012 22342012 22346012 22347012 22348012 22351012 22353012 22354012 22355012 22356012 22357012 22361012 22362012 22363012 22364012 23003012 23004012 23005012 23009012 23010012 23011012 23012012 23013012 23014012 23015012 23017012 23018012 23019012
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.