FDA recall Z-1524-2021

Product

DJO EMPOWR KNEE Femoral Sizer

Reason for recall

Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.

Distribution

U.S.: FL, IN, and MN O.U.S.: None

Key facts

Status

Ongoing

Initiation date

2021-02-05

Report date

2021-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1524-2021