Recall Z-2599-2023— Stryker Corporation

Name: FDA recall Z-2599-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-07

Class II · Ongoing

Class II FDA medical device recall by Stryker Corporation, initiated 2023-08-07. It names one FDA 510(k) clearance: K931847. Product: 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.

Recalling firm: Stryker Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-08-07
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K931847 — BIO-PREP CEMENT RESTRICTORBiomedical Devices, Inc.·cleared 1994-06-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.