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Encore Medical, Lp recalls Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implan
Recalled November 9, 2016 · FDA recall Z-0325-2017 · Encore Medical
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. · FDA Class II
Units
436 units
Sold at
US
Description
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.
Product
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →