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M/L Taper Hip Prosthesis (Zimmer) – labeling error (2023)

The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

FDAJul 26, 2023Nationwide• Zimmer, Inc.

Hamilton-MR1 Ventilator (Hamilton) – control board leak (2023)

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

Moderate

FDAJul 26, 2023Nationwide• Hamilton Medical, Inc.

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M/L Taper Hip Prosthesis (Zimmer) – labeling error (2023)

Hamilton-MR1 Ventilator (Hamilton) – control board leak (2023)

ZVU Functional GI Software (Diversatek) – revision mislabeling (2023)

RevHD Hubcaps (REVHD) – loose lens issue (2023)

ADVIA Chemistry Protein Test (Siemens) – reagent carryover (2023)

Membrane Changer (SenTec) – manufacturing material risk (2023)

O-arm O2 Imaging System (Medtronic) – ground cable problem (2023)

Mack LRBE Electric (Mack) – Battery Threaded Inserts (2023)

Cook Lead Clipper (Cook) – Sterility Compromise (2023)

Allison Transmission 6th Gen TCM (Allison) – Control Module Issue (2023)

Trigen Trochanteric Nail (Smith & Nephew) – incorrect implant (2023)

VHD (VOLVO) – windshield wiper motor issue (2023)

Volvo VNRE Electric (Volvo) – Battery Threaded Inserts (2023)

Ambu aView 2 Monitor (Ambu) – Circuit Short Risk (2023)

Ford F-350 SD (Ford) – Instrument Cluster Problem (2023)

Kenworth T280 (Kenworth) – Driveline Potential Issue (2023)

Keystone Bosworth Copaliner Varnish (Keystone) – Packaging Error (2023)

Ford F-59 (Ford) – Instrument Cluster Corrosion (2023)

Forest River Impression (Forest River) – Griddle Stowage (2023)

Ford Transit Connect (Ford) – Door Latch Failure (2023)