Encore Medical, LP: DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106

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: 20 Lot/code info: UDI-DI/Lot/Expiration: 00190446258032/308V1112/May 25, 2029

UPC codes

00190446258032

Source

Official record: FDA (Device enforcement) ↗

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