Encore Medical product recalled over labeling errors

Recall date

November 15, 2016

Source

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

Official notice title

Encore Medical, Lp recalls Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate…

Recall number

Z-0711-2017

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ

Why it was recalled

A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.

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 Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.