Recall Z-0508-2024— Encore Medical, LP

Name: FDA recall Z-0508-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-10

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2023-11-10. It names one FDA 510(k) clearance: K171991. Product: DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.. Reason: Due to incorrect product/device within packaging..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2023-11-10
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K171991 — EMPOWR Porous Knee SystemEncore Medical L.P.·cleared 2017-10-04

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 surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.

Reason for recall

Due to incorrect product/device within packaging.

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