FDA recall Z-0508-2024

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 for recall

Due to incorrect product/device within packaging.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-11-10

Report date

2023-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0508-2024