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Encore Medical, Lp recalls Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior crucia
Recalled December 14, 2016 · FDA recall Z-0711-2017 · Encore Medical
Hazard
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. · FDA Class II
Units
7 units
Sold at
US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ
Description
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.
Product
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.
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →