# FDA recall Z-0483-2025

> **Novosource, LLC** · Class II · device recall initiated 2024-09-19.

## Product

NovoHip Biolox Ball Head 32mmL  Ref: 1345-2803    NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components.

## Reason for recall

Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted

## Distribution

Florida, West Virginia

## Key facts

- **Recall number:** Z-0483-2025
- **Recalling firm:** Novosource, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-19
- **Report date:** 2024-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0483-2025

## Citation

> AI Analytics. FDA recall Z-0483-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0483-2025. Source: US FDA. Licensed CC0.

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