Encore Medical, Lp: Medical Device Recall in 2016 - (Recall #: Z-0325-2017)

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; 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: November 9, 2016

Recall Number: Z-0325-2017

Event ID: 75214

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. 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.

Status: Terminated

Product Quantity: 436 units

Code Information:

202351L01, 202434L01, 203779L01, 202351L02, 202434L02, 202351L03, 202434L03, 203779L03, 202351L04, 202434L04, 202351L05, 202434L05, 202351L06, 202434L06, 203779L06, 202351L07, 202434L07, 203779L07, 202351L08, 202434L08, 203779L08, 202351L09, 202434L09, 202351L10, 202434L10, 203203L01

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated