# FDA recall Z-2104-2021

> **Encore Medical, LP** · Class II · device recall initiated 2021-05-12.

## Product

DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185

## Reason for recall

Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.

## Distribution

US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA  OUS: None

## Key facts

- **Recall number:** Z-2104-2021
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-12
- **Report date:** 2021-07-28

- **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-2104-2021

## Citation

> AI Analytics. FDA recall Z-2104-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-2104-2021. Source: US FDA. Licensed CC0.

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