The Recall Desk

FDA (Devices) recall action 92841

Stryker Corporation recalled 7 products on 2023-09-27

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2023-09-27
Critical
0
Units
24

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • HighFDA (Devices)··2023-09-27

    Stryker bone cement cartridge nozzles may disassemble during surgical use

    Stryker is recalling bone cement cartridges because the breakaway femoral nozzle applicator tip may disassemble or break off during use, potentially causing loss of device function and foreign material in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0206-530-000
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-09-27

    Stryker ACM System Femoral Nozzle Recall for Potential Disassembly

    Stryker is recalling its ACM Advanced Cement Mixing System due to a defect in the Break-Away Femoral Nozzle that can disassemble or break off during surgical use, risking loss of device function and foreign material in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-09-27

    Stryker ACM Cement Mixer Nozzle Risk of Disassembly During Surgery

    Stryker is recalling certain ACM (Advanced Cement Mixing) systems due to risk that the Break-Away Femoral Nozzle may disassemble or break during use, potentially causing loss of function and components entering the surgical site.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-09-27

    Stryker ACM Advanced Cement Mixing System Nozzle May Disassemble

    Stryker is recalling the ACM bone cement mixing system because the break-away femoral nozzle may disassemble or break off during surgery, potentially causing loss of device function and components to fall into the surgical site.

    Product
    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-09-27

    Stryker ACM Bone Cement Mixer Nozzle May Break During Surgery

    Stryker ACM bone cement mixing system nozzles may break or disassemble during surgical use, causing loss of function and risk of material fragments in the surgical site. Users should stop using affected units.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-09-27

    Stryker ACM System nozzle may disassemble during bone cement mixing

    The break-away femoral nozzle in Stryker's ACM System may disassemble during use, potentially leaving fragments in the surgical site and causing device failure.

    Product
    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-09-27

    Stryker ACM Cement Mixing System nozzle may break during surgery

    Stryker is recalling ACM Systems due to potential breakage of the femoral nozzle applicator tip during use. This could cause device failure and leave components in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000
    Category
    Distribution
    0 states