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…

Recall date

September 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0325-2017

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

US

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.