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TREO Abdominal Stent-Graft (Bolton) – Incorrect Size (2023)

Potential for the incorrect size stent-graft than the printed carton label.

FDAMay 3, 2023Nationwide• Bolton Medical Inc.

Exeter V40 Trial Head (Howmedica) – Color Mismatch (2023)

The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.

Moderate

FDAMay 3, 2023IN• Howmedica Osteonics Corp.

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TREO Abdominal Stent-Graft (Bolton) – Incorrect Size (2023)

Exeter V40 Trial Head (Howmedica) – Color Mismatch (2023)

NOxBOXi Nitric Oxide System (Unknown) – Valve Malfunction (2023)

Legacy SmartBase (Implant Direct) – FDA Clearance (2023)

Sertera Biopsy Device (Hologic) – Needle Detachment (2023)

V-Sign Sensor 2 (SenTec) – Calibration Failure (2023)

ENGAGE Knee System (Smith & Nephew) – High Revision Rate (2023)

Serrated Blade Applicator Kit (Helena) – Packaging Mismatch (2023)

Veritor SARS-CoV-2/Flu Test (BD) – IFU Approval (2023)

Trilogy Evo Ventilator (Philips) – Sensor Debris (2023)

Trilogy Evo Universal Ventilator (Philips) – Ventilation Issue (2023)

EliA GliadinDP IgG Well (Phadia) – Result Variation (2023)

Phadia 2500EE Instrument (Phadia) – Result Variation (2023)

Trilogy Evo O2 EV300 (Philips) – Sensor Debris (2023)

Trilogy Evo O2/LifeVent (Philips) – Sensor Debris (2023)

HORIZON Microclip (Teleflex) – Clip Cartridge Issue (2023)

QIAstat-Dx Respiratory Panel (Qiagen) – False Test Results (2023)

Intelli-C Left Tabletop (NRT X-Ray) – Drive Shaft Risk (2023)

Intelli-C Right Tabletop (NRT X-Ray) – Drive Shaft Risk (2023)

MRI Biomet Pin Guide (Materialise) – Wrong Guide (2023)