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Hudson RCI Addipak (Medline) – Sterility Failure (2023)

Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.

FDAAug 4, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Reverse Shoulder System Socket Insert (DJO Surgical) – sterilization issue (2023)

Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

Moderate

FDAAug 4, 2023AL, AZ, CA +23 more

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Hudson RCI Addipak (Medline) – Sterility Failure (2023)

Reverse Shoulder System Socket Insert (DJO Surgical) – sterilization issue (2023)

CLP Hip Stem (DJO Surgical) – sterilization issue (2023)

Delta Ceramic Femoral Head (DJO Surgical) – sterilization issue (2023)

Empowr Knee Baseplate (DJO Surgical) – sterilization issue (2023)

Nelson CBC-40ST Trailer (NELSON) – steering problem (2023)

CX-90 (MAZDA) – vehicle alert system (2023)

EQE 350 4MATIC (MERCEDES-BENZ) – roof frame weakness (2023)

Tucson (HYUNDAI) – incorrect tire label (2023)

Impreza (SUBARU) – instrument panel wiring (2023)

S 580 (MERCEDES-MAYBACH) – trunk wiring issue (2023)

GV60 (GENESIS) – seat belt retractor fault (2023)

Avent Baby Monitors (Philips) – Burn risk (2023)

ReNewal Ligasure Sealer (MEDLINE) – packaging seal issue (2023)

Silverado 3500 (CHEVROLET) – steering gear issue (2023)

Gammex Non-Latex PI Green Surgical Gloves (Ansell) – pouch seal issue (2023)

Super Lite Maxx (STARCRAFT) – emergency exit issue (2023)

Novaplus Gammex Non-Latex PI Green Surgical Gloves (Ansell) – pouch seal issue (2023)

ReNewal Ligasure Maryland Jaw Sealer (MEDLINE) – packaging seal issue (2023)

ReNewal Ligasure Blunt Tip Sealer (MEDLINE) – packaging seal issue (2023)