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Encore Medical, LP recalls DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Recalled September 27, 2023 · FDA recall Z-2603-2023 · Encore Medical
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 · FDA Class II
Units
20
Sold at
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
Description
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
Product
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Manufacturer(s)
Encore Medical, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →