FDA-Device2023-11-15Class II
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Encore Medical, LP
Hazard
Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
Sold states
US: VA, TN, MN, TX, IL, IN, KY, OH, SC, MS, RI, ME, NJ, NY, MD, CA, KS, LA, PR, AL, FL, GA, AZ, WA
Affected count
406
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0258-2024Don't want to check this manually?
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