FDA-Device2016-12-14Class II
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.
Encore Medical, Lp
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.
Sold states
US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ
Affected count
7 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0711-2017Don't want to check this manually?
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