FDA-Device2016-12-21Class II
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
Encore Medical, Lp
Hazard
It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.
Sold states
Nationwide Distribution
Affected count
162 units
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0766-2017Don't want to check this manually?
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