# FDA recall Z-0508-2024

> **Encore Medical, LP** · Class II · device recall initiated 2023-11-10.

## 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

- **Recall number:** Z-0508-2024
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-10
- **Report date:** 2023-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0508-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0508-2024. Source: US FDA. Licensed CC0.

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