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Encore Medical, Lp recalls EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are
Recalled November 1, 2017 · FDA recall Z-0042-2018 · Encore Medical
Hazard
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. · FDA Class II
Units
46 units
Sold at
US Nationwide Distribution
Description
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
Product
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, 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.
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →