FDA-Device2016-11-09Class II
Empowr PS Knee System Box Cut Guide; 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. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.
Sold states
US
Affected count
436 units
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
Empowr PS Knee System Box Cut Guide; 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-0325-2017Don't want to check this manually?
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