Dispenser, Cement
FDA adverse event reports and recall history for dispenser, cement (product code KIH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 454
- Deaths
- 5
- Injuries
- 90
- Malfunctions
- 347
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
- 2015-09-16TerminatedUnder Investigation by firm
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
- 2015-06-10TerminatedNonconforming Material/Component
The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.
- 2012-03-12TerminatedMixed-up of materials/components
Flat Proximal Pressurizer. Bone cement pressurizers are intended to help seal the delivery path between the delivery nozzle and bone in order to pressurize the cement during delivery.
The firm identified two complaints have been reported indicating that the product inside the package did not match with the label information. The product was labeled as Flat Proximal Pressurizer P/N 0206-556-000 while the product inside the package was Femoral Pressurizer P/N 0206-566-000.
- 2011-09-12TerminatedPackaging
Orthovita(R) Cortoss(TM) Delivery Gun Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material
Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and handling conditions. This abrasion may cause small holes or tears in the packaging material, which may not be immediately visible to the user. Although t the Cortoss(TM) Delivery Gun is provided in double pouches and there have been no report
- TerminatedProcess design
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
Lack of an adequate sterilization validation
Monitor dispenser, cement automatically
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