# FDA recall Z-2285-2025

> **Encore Medical, LP** · Class II · device recall initiated 2025-07-09.

## Product

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704   Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

## Reason for recall

Knee implants contain incorrect labeling (size and/or side incorrect)

## Distribution

US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.

## Key facts

- **Recall number:** Z-2285-2025
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-09
- **Report date:** 2025-08-20

- **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-2285-2025

## Citation

> AI Analytics. FDA recall Z-2285-2025. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-2285-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*