Encore Medical, Lp recalls Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E…

Recall date

January 10, 2017

Source

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

Recall number

Z-1139-2017

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

Nationwide Distribution to CO, NY, and FL

Why it was recalled

The Empowr PS Insert was reported as missing the impaction slot feature.

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 Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.