Recall Z-1524-2021— Encore Medical, LP

Name: FDA recall Z-1524-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-05

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2021-02-05. It names one FDA 510(k) clearance: K143242. Product: DJO EMPOWR KNEE Femoral Sizer. Reason: Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2021-02-05
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K143242 — Rebel 3DKNEE SystemEncore Medical L.P.·cleared 2015-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.