Encore Medical, LP: DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443

Hazard

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

Details from the source

Reason for recall: 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 Distribution: US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany Quantity: 10 Lot/code info: UDI-DI/Lot/Expiration: 00888912076210/878B1171/May 2, 2027

UPC codes

00888912076210

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.