Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Empowr PS Knee System Box Cut Guide The EMPOWER PS Recalled by Encore Medical, Lp Due to It has been discovered that during Empowr PS...

Date: September 19, 2016
Company: Encore Medical, Lp
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Encore Medical, Lp directly.

Affected 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

Quantity: 162 units

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Encore Medical, Lp

Encore Medical, Lp has 43 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report