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Ionolux (Voco) – Plunger Fitting Error (2024)

Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.

Moderate

FDAJan 25, 2024IA, NY, PA +1 more• Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany

1.5MM Drill Bit (Synthes) – Sterility Concerns (2024)

Products not sterilized, sterility cannot be confirmed

High

FDAJan 24, 2024Nationwide• Synthes (USA) Products LLC

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Ionolux (Voco) – Plunger Fitting Error (2024)

1.5MM Drill Bit (Synthes) – Sterility Concerns (2024)

TFNA Femoral Nail 11mm (Synthes) – Sterility Concerns (2024)

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Impression Coping (Thommen) – Canal Depth Issue (2024)

Opal Intervertebral Cage (Synthes) – Sterility Concerns (2024)

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ADVIA Centaur EPO Assay (Siemens) – Result Bias (2024)

2.5mm Drill Bit (Synthes) – Sterilization Uncertainty (2024)

Atellica IM EPO Assay (Siemens) – Result Bias (2024)

Stay-Safe Luer Lock Catheter Extension (Fresenius) – Leachable Concerns (2024)

CVS Health Wound Tracking Dressing (Medline) – Failed Sterility Test (2024)

Stay-Safe Luer Catheter Extension (Fresenius) – Leachable Concerns (2024)

Stay-Safe Safe Lock Catheter Extension (Fresenius) – Leachable Concerns (2024)

Stay-Safe Luer Lock Adapter (Fresenius) – Leachable Concerns (2024)

Battery Mobile X-ray Unit (Sedecal) – Anti-Fall System Interference (2024)

VITROS 3600 Immunodiagnostic System (Ortho-Clinical) – Sample Aspiration Risk (2024)