FDAFDA · Food and drugs·Recall number Z-0711-2017
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.
Published December 14, 2016 · Recall initiated: November 15, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Encore Medical, Lp
- Distributor
- US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ
- Lot
- 033T1022
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.