Encore Medical, Lp: Medical Device Recall in 2016 - (Recall #: Z-0766-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 19, 2016

Date Posted: December 21, 2016

Recall Number: Z-0766-2017

Event ID: 75645

Reason for Recall:

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.

Status: Terminated

Product Quantity: 162 units

Code Information:

202351L01, 202351L02, 202351L03, 202351L04, 202351L05, 202351L06, 202351L07, 202351L08, 202351L09, 203779L09, 202351L10, 203779L10, 203203L01

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated