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Recall Observatory FDA recall evidence

Device 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.

Z-0711-2017

November 15, 2016

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 75715
Status
Terminated
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-0711-2017

Official wording

Reason: 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.

Code information: 033T1022

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled