# FDA recall Z-2604-2023

> **Encore Medical, LP** · Class II · device recall initiated 2023-08-04.

## Product

DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443

## Reason for recall

Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

## Distribution

US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA.  OUS: Sweden, Australia, France, UK, Colombia, Germany

## Key facts

- **Recall number:** Z-2604-2023
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-04
- **Report date:** 2023-09-27

- **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-2604-2023

## Citation

> AI Analytics. FDA recall Z-2604-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2604-2023. Source: US FDA. Licensed CC0.

---

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