Mixer, Cement, For Clinical Use

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-04-29Open, ClassifiedUnder Investigation by firm

  Heraeus, PALAMIX uno. Material Number: 66057893.

  Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).

• 2026-04-29Open, ClassifiedUnder Investigation by firm

  Heraeus, PALAMIX duo. Material Number: 66057897.

  Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).

• 2026-04-24Open, ClassifiedVendor change control

  Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A

  Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.

• 2013-11-14TerminatedNonconforming Material/Component

  Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.

  On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15, 2013, when the product was going to be placed in the pouch to be sealed, the manufacturing operator noticed that some assemblies were cracked. As a result of the injection pressure of the cement gun, a cracked tiplet may release from the Hub during cement applica

• 2012-01-25TerminatedComponent change control

  Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Stryker Instruments, Kalamazoo, MI Part Number: 0505-585-000, Lot:11223012 13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 13G Bevel Tip Stylet - PIN 0306-131-012 The intended use of the Stryker PCD System is for mixing bone cement and delivering it percutaneously. Bone cement is mixed in the chamber then transferred directly into an extension nozzle which has been attached to the introduction needle in the fracture site by a luer lock fitting. Cement is then dispensed directly into the fracture site under fluoroscopy

  Product was packaged with a four inch needle in stead of the correct five inch needle. There is a potential that the needle may not be able to reach the fracture site, which may require additional medical intervention. In addition, if the stylet needs to be changed and the additional stylet that comes in the package is used, this additional stylet is one inch longer than the needle. which could l

• 2011-03-11TerminatedOther

  Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1B; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.

  Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.

• 2009-06-30TerminatedPackaging process control

  Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000. Vacuum mixing and vacuum collection system and application system for bone cement.

  The package may contain two short mixing rods instead of one long and one short rod.

• 2008-05-01TerminatedNonconforming Material/Component

  Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.

  Sterility may be compromised, as the packaging may have channels in the packaging seal.

• 2008-03-11TerminatedLabeling Change Control

  Stryker VertePort, 10 G Access Cannula w/Long Stylet System, REF 306-400, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.

  Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy)

• 2008-03-11TerminatedLabeling Change Control

  Stryker VertePort, 10 G Cement Cannula, REF 306-410, Qty 18; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.

  Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy)