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

FDA Recall #Z-0508-2024 — Class II — November 10, 2023

Recall #Z-0508-2024 Date: November 10, 2023 Classification: Class II Status: Ongoing

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.

Recalling Firm

Encore Medical, LP — Austin, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

37 devices

Distribution

US Nationwide distribution.

Code Information

Model Number: 243-01-108 UDI-DI Code: 00190446231295 Lot Number: 277W1114 Model Number: 353-03-108 UDI-DI Code: 00190446231295 Lot Number: 213W1051

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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