Z-0508-2024Class II

DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF...

Name: Z-0508-2024 DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF...
Creator: Encore Medical, LP
Published: 2023-11-10
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2023-11-10 / Open, Classified / root cause: labeling and UDI

FDA source

Encore Medical, LP began a recall of 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... on 2023-11-10. FDA classified it as Class II and gives the reason as "Due to incorrect product/device within packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0508-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-10
Posted: 2023-12-07
Recalling firm: Encore Medical, LP
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.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Due to incorrect product/device within packaging.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Quantity in commerce: 37 devices
Distribution: US Nationwide distribution.
Product codes and lots: Model Number: 243-01-108 UDI-DI Code: 00190446231295 Lot Number: 277W1114 Model Number: 353-03-108 UDI-DI Code: 00190446231295 Lot Number: 213W1051

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0508-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0508-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-07

Product code MBH

K171991Class IIEMPOWR Porous Knee SystemEncore Medical L.P. / cleared 2017-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)