Stryker Corporation: Medical Device Recall in 2023 - (Recall #: Z-2596-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.

Product Classification:

Class II

Date Initiated: August 7, 2023

Date Posted: September 27, 2023

Recall Number: Z-2596-2023

Event ID: 92841

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

Status: Ongoing

Product Quantity: 109 units US; 290 units OUS

Code Information:

GTIN: 04546540039415 Lot Numbers: 22314012 22336012

Distribution Pattern:

Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK

Voluntary or Mandated:

Voluntary: Firm initiated