Encore Medical, Lp: Medical Device Recall in 2017 - (Recall #: Z-0041-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

Product Classification:

Class II

Date Initiated: September 15, 2017

Date Posted: November 1, 2017

Recall Number: Z-0041-2018

Event ID: 78193

Reason for Recall:

It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.

Status: Terminated

Product Quantity: 48 units

Code Information:

Lot Number 287U1004

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated