# FDA recall Z-0766-2025

> **Encore Medical, LP** · Class II · device recall initiated 2024-12-18.

## Product

EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705;  EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703

## Reason for recall

5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.

## Distribution

US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.

## Key facts

- **Recall number:** Z-0766-2025
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-18
- **Report date:** 2025-01-01

- **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-0766-2025

## Citation

> AI Analytics. FDA recall Z-0766-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0766-2025. Source: US FDA. Licensed CC0.

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