FDA-Device2021-05-12Class II
DJO EMPOWR KNEE Femoral Sizer
Encore Medical, LP
Hazard
Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
Sold states
U.S.: FL, IN, and MN O.U.S.: None
Affected count
16 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
DJO EMPOWR KNEE Femoral Sizer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1524-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief