# FDA recall Z-0103-2024

> **Encore Medical, LP** · Class II · device recall initiated 2023-08-22.

## Product

EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H

## Reason for recall

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

## Distribution

US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.

## Key facts

- **Recall number:** Z-0103-2024
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-22
- **Report date:** 2023-10-18

- **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-0103-2024

## Citation

> AI Analytics. FDA recall Z-0103-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0103-2024. Source: US FDA. Licensed CC0.

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