FDA-Device2023-09-27Class II
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Encore Medical, LP
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
Sold states
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
Affected count
20
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2603-2023Don't want to check this manually?
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