medical Class II Updated 2023-09-27

Encore Medical, LP recalls DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, RE

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Affected States: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WA

Lot/Code Info: UDI-DI/Lot/Expiration: 00190446258032/308V1112/May 25, 2029

View official government recall

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