Encore Medical, Lp recalls EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are…

Recall date

September 15, 2017

Source

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

Recall number

Z-0041-2018

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

US Nationwide Distribution

Why it was recalled

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

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(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.